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NDC 61776-0001-03 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 CMS Imaging Inc dba Medco. The primary component is OXYGEN.

Product Information

NDC	61776-0001
Product ID	61776-0001_3c41aa3d-a32e-4544-b00d-a6d349fb6a37
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	CMS Imaging Inc dba Medco
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 61776-0001-03 (61776000103)

Pricing Information	N/A
NDC Package Code	61776-0001-3
Billing NDC	61776000103
Package	675 L in 1 CYLINDER (61776-0001-3)
Marketing Start Date	1987-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2c4b5cef-a387-4bd2-95d8-adc858b6c824 Details

SPL UNCLASSIFIED SECTION

WARNING: SECURE ALL CYLINDERS WHILE IN STORAGE AND IN USE. 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 CONJUNCTION WITH RESUSCITATIVE EQUIPMENT. USE IN ACCORDANCE WITH MATERIAL SAFETY DATA SHEETS AND SAFETY PRECAUTIONS RECOMMENDED BY THE SUPPLIER.

WARNING: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION. PRODUCED BY AIR LIQUEFACTION. DO NOT REMOVE THIS PRODUCT LABEL.

OXYGEN LABEL

OXYGEN COMPRESSED U.S.P. UN 1072 OXYGEN-2

FOR EMERGENCY USE ONLY WHEN ADMINISTERED BY PROPERLY TRAINED PERSONNEL FOR OXYGEN DEFICIENCY AND RESUSCITATION. FOR ALL OTHER MEDICAL APPLICATIONS Rx ONLY.

NET CONTENTS:____________________________

res

INGREDIENTS AND APPEARANCE

OXYGEN

oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:61776-0001
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:61776-0001-1	170 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1987
2	NDC:61776-0001-2	426 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1987
3	NDC:61776-0001-3	675 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1987

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved medical gas		01/01/1987

Labeler - CMS Imaging Inc dba Medco (927819409)

Registrant - CMS Imaging Inc dba Medco (927819409)

Name	Address	ID/FEI	Business Operations
Establishment
Medco		927819409	manufacture(61776-0001)

Revised: 11/2022

Document Id: 3c41aa3d-a32e-4544-b00d-a6d349fb6a37

Set id: 2c4b5cef-a387-4bd2-95d8-adc858b6c824

Version: 4

Effective Time: 20221103