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NDC 59910-0001-08 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 McDonald Welding Supply, Inc. The primary component is OXYGEN.

Product Information

NDC	59910-0001
Product ID	59910-0001_eb3ca265-26a3-7478-e053-2a95a90a72c1
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	McDonald Welding Supply, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA205865
Listing Certified Through	2023-12-31

Package

Package Images

NDC 59910-0001-08 (59910000108)

Pricing Information	N/A
NDC Package Code	59910-0001-8
Billing NDC	59910000108
Package	6896 L in 1 CYLINDER (59910-0001-8)
Marketing Start Date	1976-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a48b258f-cc6b-4151-9cd7-4fde2ec4ebae Details

OXYGEN COMPRESSED LABEL

OXYGEN COMPRESSED USP UN 1072 OXYGEN-2

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. 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. PRODUCED BY AIR LIQUEFACTION.

WARNING: HIGH PRESSURE OXIDIZING GAS. VIGOROUSLY ACCELERATES COMBUSTION. KEEP OIL AND GREASE AWAY. OPEN VALVE SLOWLY. STORE AND USE WITH ADEQUATE VENTILATION. USE ONLY WITH EQUIPMENT CLEANED FOR OXYGEN SERVICE AND RATED FOR CYLINDER PRESSURE. CLOSE VALVE AFTER EACH USE AND WHEN EMPTY. CYLINDER TEMPERATURE SHOULD NOT EXCEED 52 C (125 F) USE IN ACCORDANCE WITH THE MATERIAL SAFETY DATA SHEET (MSDS) CAS 7782-44-7 RETURN WITH 25 PSIG. DO NOT REMOVE THIS PRODUCT LABEL.

LOT#_____________________ CONTENTS_________________________ 17033 (R 05/01)

INGREDIENTS AND APPEARANCE

OXYGEN

oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:59910-0001
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:59910-0001-1	255 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1976
2	NDC:59910-0001-2	426 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1976
3	NDC:59910-0001-3	671 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1976
4	NDC:59910-0001-4	1260 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1976
5	NDC:59910-0001-5	1540 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1976
6	NDC:59910-0001-6	2240 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1976
7	NDC:59910-0001-7	3584 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1976
8	NDC:59910-0001-8	6896 L in 1 CYLINDER; Type 0: Not a Combination Product	01/01/1976

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA205865	01/01/1976

Labeler - McDonald Welding Supply, Inc (027106186)

Registrant - McDonald Welding Supply, Inc (027106186)

Name	Address	ID/FEI	Business Operations
Establishment
McDonald Welding Supply, Inc		027106186	manufacture(59910-0001)

Revised: 10/2022

Document Id: eb3ca265-26a3-7478-e053-2a95a90a72c1

Set id: a48b258f-cc6b-4151-9cd7-4fde2ec4ebae

Version: 4

Effective Time: 20221017