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NDC 58662-0001-00 OXYGEN 992 mL/L Details

OXYGEN 992 mL/L

OXYGEN is a RESPIRATORY (INHALATION) GAS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Home Medical Products and Services, LLC. The primary component is OXYGEN.

Product Information

NDC	58662-0001
Product ID	58662-0001_ee16b702-8566-37d5-e053-2995a90aae3f
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	992
Active Ingredient Units	mL/L
Substance Name	OXYGEN
Labeler Name	Home Medical Products and Services, LLC
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 58662-0001-00 (58662000100)

Pricing Information	N/A
NDC Package Code	58662-0001-0
Billing NDC	58662000100
Package	682 L in 1 CYLINDER (58662-0001-0)
Marketing Start Date	2014-08-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 04e44d1b-b5fa-45e3-8320-40017ea55c1d Details

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:58662-0001
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065)	OXYGEN	992 mL in 1 L

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58662-0001-0	682 L in 1 CYLINDER; Type 0: Not a Combination Product	08/04/2014
2	NDC:58662-0001-1	425 L in 1 CYLINDER; Type 0: Not a Combination Product	08/04/2014
3	NDC:58662-0001-3	164 L in 1 CYLINDER; Type 0: Not a Combination Product	08/04/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved medical gas		08/04/2014

Labeler - Home Medical Products and Services, LLC (796001886)

Name	Address	ID/FEI	Business Operations
Establishment
Home Medical Products and Services, LLC		020839902	manufacture(58662-0001)

Name	Address	ID/FEI	Business Operations
Establishment
Home Medical Products and Services, LLC		836566489	manufacture(58662-0001)

Revised: 11/2022

Document Id: ee16b702-8566-37d5-e053-2995a90aae3f

Set id: 04e44d1b-b5fa-45e3-8320-40017ea55c1d

Version: 8

Effective Time: 20221122