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NDC 54619-0001-07 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 Red Ball Medical Supply. The primary component is OXYGEN.

Product Information

NDC	54619-0001
Product ID	54619-0001_d57d00f9-1caf-82e2-e053-2995a90ade6a
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	Red Ball Medical Supply
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 54619-0001-07 (54619000107)

Pricing Information	N/A
NDC Package Code	54619-0001-7
Billing NDC	54619000107
Package	640 L in 1 CYLINDER (54619-0001-7)
Marketing Start Date	2009-05-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1669da72-d109-42bf-80cd-036af38b3a67 Details

Principal for Oxygen Product

OXYGEN

COMPRESSED

USP

UN 1072

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.

CAS NO: 7782-44-7

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:54619-0001
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:54619-0001-1	170 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2009
2	NDC:54619-0001-2	248 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2009
3	NDC:54619-0001-7	640 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2009
4	NDC:54619-0001-4	682 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2009
5	NDC:54619-0001-6	164 L in 1 CYLINDER; Type 0: Not a Combination Product	05/22/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved medical gas		05/22/2009

Labeler - Red Ball Medical Supply (079766093)

Registrant - Red Ball Medical Supply (079766093)

Name	Address	ID/FEI	Business Operations
Establishment
Red Ball Medical Supply		079766093	manufacture(54619-0001)

Revised: 1/2022

Document Id: d57d00f9-1caf-82e2-e053-2995a90ade6a

Set id: 1669da72-d109-42bf-80cd-036af38b3a67

Version: 5

Effective Time: 20220113