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Dosage Form: gas

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WARNINGS SECTION

WARNING: For emergency use only when administered by properly trained personnel for Oxygen deficiency and resuscitation. For all other medical applications, Rx only.

Uninterrupted use of high concentrations of Oxygen over a long duration, without monitoring its effect on Oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Patient monitoring is recommended for patient receiving supplemental Oxygen. Flow rates for this product are approximate. Federal law restricts this device to sale by or on the order of a physician.

Keep out of reach and sight of children.

Federal law requires that this container be refilled with Oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.

Note: Keep valve minimum 12 inches (30cm) away from magnet opening. Do not move the package during MRI scan, as the MR data quality may be degraded.

Un-Coded Section

MR
MR CONDITIONAL
Static Field Strength 3.0T
Static Field Gradient 375 Gauss/cm

Instructions for use
-Operating temperature -4°F to 113°F (-20°C to +45°C)
-Only use with devices intended for the product administration.
-Prepare to change the cylinder when the pointer on the gauge enters the red area.
-to ensure the correct, prescribed flow rate, always make sure that the flow selector is positioned on a numbered flro setting, not between flow settings.


1) Pressure outlet (if provided)
2) Shut-off valve
3) Gauge
4) Flow outlet
5) Flow selector

Before Use:
>Check gauge (3) for content.
>Check flow selector (5) is set at zero.
>Connect equipment to outlet (1 or 4).
>Slowly open shut off valve (2) fully by turning counterclockwise.
>If equipment is connected to the flow outlet (4) select flow by turning flow selector (5) stepwise up through flow settings.
The patient can now be connected to a deliver device.

After Use:
>Turn flow selector (5) to zero by turning the flow selector stepwise down through flow settings.
>Close shut off valve (2) by turning clockwise.
>Vent downstream equipment.
>Disconnect the equipment from the outlet (1 or 4).
 

Batch:


DO NOT REMOVE THIS LABEL


LG016
(03/15)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL     

Linde
Oxygen, COMPRESSED USP UN1072

Produced By Air Liquefaction

CAS 7782-44-7

Distributed by:
Linde Gas North America LLC
575 Mountain Ave.
Murray Hill, NJ 07974
866.543.3427

Oxygen 2

MEDICAL GAS

WARNING: For emergency use only when administered by properly trained personnel for Oxygen deficiency and resuscitation. For all other medical applications, Rx only.

Uninterrupted use of high concentrations of Oxygen over a long duration, without monitoring its effects on Oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Federal law requires that this container be refilled with Oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.

DANGER:
KEEP OUT OF REACH OF CHILDREN.
MAY CAUSE OR INTENSIFY FIRE: OXIDIZER
CONTAINS GAS UNDER PRESSURE: MAY EXPLODE IF HEATED.

Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for Oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.

DO NOT REMOVE THIS LABEL.

CONTENTS:
Cylinder
Type
Liters   
T 8584 [_]
H 6322 [_]
K 6322 [_]
M 3172 [_]
F 1567 [_]
E 680 [_]
DD 588 [_]
D 413 [_]
C 248 [_]
BB 147 [_]
B 147 [_]
AA 103 [_]
AAA 39 [_]
M-7 196 [_]

LG010E
(R 11/14)

Linde
Oxygen, COMPRESSED USP

UN1072

Produced by Air Liquefaction

CAS 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL.

Oxygen 2
LG011E
(R 11/14)

MEDICAL GAS

WARNING: For emergency use only when administered by properly trained personnel for Oxygen deficiency and resuscitation. For all other medical applications, Rx only. Uninterrupted use of high concentrations of Oxygen over a long duration, without monitoring its effects on Oxygen content or arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use an store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for Oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.  

Distributed by: 
Linde Gas North America LLC
575 Mountain Ave.
Murrray Hill, NJ 07974 
866.543.3427

CONTENTS:
Cylinder
Type
  Liters
T [_] 8584
H [_] 6322
K [_] 6322
M [_] 3172
____ ____ ____

MR CONDITIONAL
Static Field Strength ≤ 3.0T
Spatial Gradient Field ≤ 100 gauss/cm

Oxygen, COMPRESSED
USP
UN1072
CAS 7782-44-7
Produced by Air Liquefaction.

Distributed by:
Linde Gas North America, LLC
575 Mountain Ave.
Murray Hill, NJ 07974
866.513.3427

CONTENTS:
Cylinder Type   Liters
E [_] 680
D [_] 413

No user-serviceable parts. Return to distributor for service/repair. MR conditional void if user-serviced.

No user transfill. Return to distributer for transfill.

Oxygen 2

Linde

ACCURACY: ±20%: 1, 1.5, 2 lpm
  ±15%: 3 lpm
  ±10%: 4 ,5 ,8 ,10 ,15 lpm
FOR MRI: derate by -3.5% at 1.5T
  derate by -12% at 3.0T

MR CONDITIONAL
Static Field Strength ≤ 3.0T
Spatial Gradient Field ≤ 100 gauss/cm

INDICATIONS FOR USE: Intended to provide supplemental Oxygen to adults, MRI safe, MRI-compatible, and intended for use during MRI imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for Oxygen deficiency and resuscitation. For all other medical applications, Rx only.

WARNING: For emergency use only when administered by properly trained personnel for Oxygen deficiency and resuscitation. For all other medical applications, Rx only. Uninterrupted use of high concentrations of Oxygen over a long duration, without monitoring its effect on Oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment. Keep out of reach of children. Federal law requires that this container be refilled with Oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for Oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when the ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.

DO NOT REMOVE THIS LABEL.

MRI
CAUTION
≤ 3.0T
≤ 100 G/cm

NOTICE
-Open valve slowly. Close after each use.


-Environmental specifications for handling, storage, transport, and operating conditions: -20 to 125°F (-29 to 52°C).

(R 01/15)
LG013E

MR CONDITIONAL
Static Field Strength ≤ 3.0T
Static Field Gradient ≤ 375 Gauss/cm

Oxygen, COMPRESSED
USP
UN 1072
CAS: 7782-44-7

Produced by Air Liquefaction

CONTENTS:
Cylinder type:   Liters
E ___ 1004
D ___ 618

ACCURACY:
          ±20%: 3.0 lpm
          ±10%: > 3.0 lpm

SERVICE and TRANSFILL:
No user-serviceable parts.
Return to distributor for service/repair.
MR conditional void if user-serviced.
No user tranfill. Return to distributor for transfill.

Linde
Distributed by:
Linde Gas North America, LLC
575 Mountain Ave.
Murray Hill, NJ 07974
866.543.3427

Oxygen 2

MR CONDITIONAL
Static Field Strength ≤
3.0T
Static Field Gradient ≤
375 Gauss/cm

INDICATIONS FOR USE: Intended to provide supplemental Oxygen to adults. MRI safe, MRI-compatible, and intended for use during MRI imaging for MRI systems up to 3.0T.

DANGER: MAY CAUSE OR INTENSIFY FIRE: OXIDIZER. CONTAINS GAS UNDER PRESSURE: MAY EXPLODE IF HEATED. Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for Oxygen service. Open valve slowly. Close valve after each use and when empty. Protect form sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.

USP
WARNING:
For emergency use only when administered by properly trained personnel for Oxygen deficiency and resuscitation. For al other medical applications, Rx only. Uninterrupted use of high concentrations of Oxygen over a long duration, without monitoring its effects on Oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjunction with resuscitative equipment Federal law requires that this container be refilled with Oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act. Keep out of reach of children.

DO NOT REMOVE THIS PRODUCT LABEL.

MR CONDITIONAL
Static Field Strength ≤ 3.0T
Static Field Gradient ≤ 375 Gauss/cm

NOTICE

-Open valve slowly. Close after each use.


-Environmental specifications for handling, storage, transport, and operations conditions: -20 to +125°F (-29 to +52°C)

LG014C
(R 11/14)

THE LINDE GROUP
Linde

Oxygen,
COMPRESSED
USP

Oxygen
2

UN1072
CAS: 7782-44-7

Produced by Air Liquefaction
Oxygen (O2) 100%
under 2000 psi pressure (59°F or 15°C)

CONTENTS:
Cylinder type: Liters
E [_] 680
D [_] 413

Service and transfill:
No user-serviceable parts. Return to distributor for service/repair. MRI safe and MRI compatible void if user-serviced. No user transfill. Return to distributor for transfill.


Distributed by:
Linde Gas North America LLC
575 Mountain Ave.
Murray Hill, NJ 07974
866.543.3427

MR
MR CONDITIONAL


Static Field Strength 3.0T
Static Field Gradient 375 Gauss/cm

LIV®


INDICATIONS FOR USE:
The LIV® is an integrated portable Oxygen delivery system intended to provide supplemental Oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T.


Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling or rolling.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED.

Do not handle until all safety precautions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire: Stop leak if safe to do so. Use a back flow preventive device in the piping. Use only with equipment of compatible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for Oxygen service. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52°C (125°F). Read and follow the Safety Data Sheet (SDS) before use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LINDE


MEDICAL GAS

Oxygen  
Oxygen gas
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:25373-001
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxygen (Oxygen) Oxygen 99 L  in 100 L
Packaging
# Item Code Package Description
1 NDC:25373-001-01 413 L in 1 CYLINDER
2 NDC:25373-001-02 640 L in 1 CYLINDER
3 NDC:25373-001-03 6452 L in 1 CYLINDER
4 NDC:25373-001-04 34 L in 1 CYLINDER
5 NDC:25373-001-05 113 L in 1 CYLINDER
6 NDC:25373-001-06 170 L in 1 CYLINDER
7 NDC:25373-001-07 170 L in 1 CYLINDER
8 NDC:25373-001-08 196 L in 1 CYLINDER
9 NDC:25373-001-09 248 L in 1 CYLINDER
10 NDC:25373-001-10 680 L in 1 CYLINDER
11 NDC:25373-001-17 1567 L in 1 CYLINDER
12 NDC:25373-001-18 3172 L in 1 CYLINDER
13 NDC:25373-001-19 6322 L in 1 CYLINDER
14 NDC:25373-001-20 8584 L in 1 CYLINDER
15 NDC:25373-001-15 1004 L in 1 CYLINDER
16 NDC:25373-001-16 618 L in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved medical gas 11/19/1990
Labeler - Linde Gas North America LLC (805568339)
Registrant - Linde Gas North America LLC (805568339)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 010263301 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 016271697 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 833132561 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 010596159 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 143956550 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 941118262 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 145259227 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 069239874 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 960788508 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 784579190 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 805823411 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 016300933 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 164139060 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 026921048 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 155946564 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 361385771 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 129012352 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 142591424 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 833119261 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 172749546 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 624186131 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 168248081 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 067906953 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 789082976 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 149324605 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 833120244 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 805342578 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 833120426 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 166471248 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 555579254 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 833120723 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 153448761 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 134971428 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 181444840 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 167911036 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 839176356 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 069232473 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 142984488 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 160443631 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 190750658 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 833132108 MANUFACTURE(25373-001)
Establishment
Name Address ID/FEI Operations
Linde Gas North America LLC 080006834 manufacture(25373-001)
Revised: 01/2016
 
Linde Gas North America LLC



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