Oxygen

OXYGEN, COMPRESSED USP UN 1072 OXYGEN 2 (R-K14) XXXXXX

GCS-OXYUSP-XXX-PK500 7/12/18

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.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 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.

BioMedic Systems, Inc.

Road 176, KM 5.4, San Juan PR 00926

787-748-3868

CONTENTS:

IN CU. FT.

BMS-03

(08/18)

Oxygen Label

OXYGEN
oxygen gas

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:72574-001
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:72574-001-01	113 L in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2018
2	NDC:72574-001-02	170 L in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2018
3	NDC:72574-001-03	255 L in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2018
4	NDC:72574-001-04	425 L in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2018
5	NDC:72574-001-05	566 L in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2018
6	NDC:72574-001-06	679 L in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2018
7	NDC:72574-001-07	1132 L in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2018
8	NDC:72574-001-08	3114 L in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2018
9	NDC:72574-001-09	4247 L in 1 CYLINDER; Type 0: Not a Combination Product	07/01/2018
10	NDC:72574-001-10	6228 L in 1 DEWAR; Type 0: Not a Combination Product	07/01/2018
11	NDC:72574-001-11	9540 L in 1 DEWAR; Type 0: Not a Combination Product	07/01/2018
12	NDC:72574-001-12	164793 L in 1 DEWAR; Type 0: Not a Combination Product	07/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA205849	07/01/2018

Labeler - Biomedics Systems, Inc. (078435830)

Name	Address	ID/FEI	Business Operations
Establishment
Biomedics Systems, Inc.		078435830	manufacture(72574-001)