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NDC 51194-0123-13 Oxygen 99 L/100L Details

Oxygen 99 L/100L

Oxygen is a RESPIRATORY (INHALATION) GAS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Calox Inc. The primary component is OXYGEN.

Product Information

NDC	51194-0123
Product ID	51194-123_ec1ea90d-3def-c012-e053-2995a90afc7f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Oxygen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Oxygen
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	GAS
Route	RESPIRATORY (INHALATION)
Active Ingredient Strength	99
Active Ingredient Units	L/100L
Substance Name	OXYGEN
Labeler Name	Calox Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED MEDICAL GAS
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 51194-0123-13 (51194012313)

Pricing Information	N/A
NDC Package Code	51194-123-13
Billing NDC	51194012313
Package	230 L in 1 DEWAR (51194-123-13)
Marketing Start Date	2007-05-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7d6715b5-6a13-0df0-e053-2991aa0ac0d1 Details

Principal for Oxygen Product

OXYGEN

COMPRESSED

USP

UN 1072

PRODUCED BY AIR LIQUIFICATION

WARNING: HIGH PRESSURE OXIDIZING GAS, VIGOROUSLY ACCELERATES COMBUSTION. NO SMOKING IN THE PRESENCE OF OXYGEN OR A FIRE MAY RESULT.

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

WARNING: Federal law prohibits dispensing without prescription. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Use only with pressure reducing equipment and apparatus designed for oxygen. Do not attempt to use on patients who have stopped breathing, unless used in conjuction with resuscitative equipment.

WARNING: Keep oil and grease away. Use only with equipment cleaned for oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty.

USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEET.

DO NOT REMOVE THIS PRODUCT LABEL.

OXYGEN,

REFRIGERATED

LIQUID USP

UN 1073

CONTENTS ________________LITERS

CAS NO: 7782-44-7

DANGER:

MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS

REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR

INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON

IGNITION OR IMPACT.

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. Wear cold insulating gloves, face

shield, and eye protection. 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. DO NOT change or force

fit connections. Avoid spills. Do not walk on or roll equipment over spills.

Close valve after each use and when empty. Always keep container in

upright position. Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID:

IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected

area. Get immediate medical advice/attention.

DO NOT REMOVE THIS PRODUCT LABEL.

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.

Produced by Air Liquefaction.

INGREDIENTS AND APPEARANCE

OXYGEN

oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:51194-123
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	99 L in 100 L

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51194-123-01	113 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
2	NDC:51194-123-02	165 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
3	NDC:51194-123-03	164 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
4	NDC:51194-123-04	198 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
5	NDC:51194-123-05	255 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
6	NDC:51194-123-06	425 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
7	NDC:51194-123-07	640 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
8	NDC:51194-123-08	680 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
9	NDC:51194-123-09	1738 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
10	NDC:51194-123-10	3455 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
11	NDC:51194-123-11	7080 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2007
12	NDC:51194-123-12	180 L in 1 DEWAR; Type 0: Not a Combination Product	05/22/2007
13	NDC:51194-123-13	230 L in 1 DEWAR; Type 0: Not a Combination Product	05/22/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved medical gas		05/22/2007

Labeler - Calox Inc (005991484)

Name	Address	ID/FEI	Business Operations
Establishment
Calox Inc		005991484	manufacture(51194-123)

Revised: 10/2022

Document Id: ec1ea90d-3def-c012-e053-2995a90afc7f

Set id: 7d6715b5-6a13-0df0-e053-2991aa0ac0d1

Version: 5

Effective Time: 20221028