OXYGEN- oxygen gas 
Rotech Healthcare Inc

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Oxygen

OXYGEN, COMPRESSED USP

UN1072

PRODUCED BY AIR LIQUEFACTION

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. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and Cosmetic Act. 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. 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. oxygen one

OXYGEN, REFRIGERATED LIQUID USP

UN1073

PRODUCED BY AIR LIQUEFACTION

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. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only be establishments registered as a drug manufacturer in accordance with the Federal Food, Drug, and Cosmetic Act.

DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER. CONTAINS REFRIGERATED GAS; MAY CAUSE CRYOGENIC BURNS OR INJURY. COMBUSTIBLES IN CONTACT WITH LIQUID OXYGEN MAY EXPLODE ON IGNITION OR IMPACT. 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 well-ventilated place. Wear cold insulating gloves, face shield, and eye protection. In case of fire: Stop the flow of oxygen 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. DO NOT change or force fit connections. Avoid spills. Do not walk on or roll equipment over spills. Close valve after each use and when empty. Always keep container in upright position. Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID: IF ON SKIN: Thaw frosted parts with lukewarm water. Do not rub affected area. Get immediate medical advice/attention. CAS: 7782-44-7

DO NOT REMOVE THIS PRODUCT LABEL oxygen two

OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57439-003
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN990 mL  in 1 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57439-003-083455 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
2NDC:57439-003-097100 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
3NDC:57439-003-109430 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
4NDC:57439-003-01113 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
5NDC:57439-003-02170 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
6NDC:57439-003-03255 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
7NDC:57439-003-04425 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
8NDC:57439-003-05680 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
9NDC:57439-003-061738 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
10NDC:57439-003-072549 L in 1 CYLINDER; Type 0: Not a Combination Product01/01/2018
11NDC:57439-003-1120 L in 1 DEWAR; Type 0: Not a Combination Product01/01/2018
12NDC:57439-003-1230 L in 1 DEWAR; Type 0: Not a Combination Product01/01/2018
13NDC:57439-003-1332 L in 1 DEWAR; Type 0: Not a Combination Product01/01/2018
14NDC:57439-003-1437 L in 1 DEWAR; Type 0: Not a Combination Product01/01/2018
15NDC:57439-003-1545 L in 1 DEWAR; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20588901/01/2018
Labeler - Rotech Healthcare Inc (144556222)
Registrant - Rotech Healthcare Inc (144556222)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH016953296manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
RHEMA MEDICAL078670599manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Plus, Inc. dba Summit Respiratory079569918manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
HEARTLAND HOME HEALTH CARE079570162manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH079570216manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
MAJOR MEDICAL079607390manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH079607401manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
COMMUNITY HOME OXYGEN079607617manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH HOME MEDICAL CARE079607622manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
FIRST CARE079639101manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH OF ARLINGTON HEIGHTS079713679manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH079721579manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
MAJOR MEDICAL SUPPLY079721904manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH079738728manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
KELLEY'S HOME HEALTH SERVICES079738768manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
G&G MEDICAL085400138manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH098136096manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
SUMMIT RESPIRATORY135922784manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
CPO2148713329manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH159346050manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
HOME CARE MEDICAL SERVICES169932436manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
Sentry Home Health174392501manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTH MEDICAL179387050manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH611480690manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
CAMBRIA MEDICAL SUPPLY620007021manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
HOME MEDICAL SYSTEMS795469142manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
SENTRY HOME HEALTH796502123manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
G&G MEDICAL796502479manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTH MEDICAL831552364manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
SUMMIT RESPIRATORY831552372manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH831562918manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
FAMILY HOME CARE831748491manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
GREAT LAKES HOME MEDICAL831831172manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTECH833186922manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
MED-AIR TRANSFILL841973667manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
SUMMIT RESPIRATORY874476422manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
ROTH MEDICAL948744180manufacture(57439-003)
Establishment
NameAddressID/FEIBusiness Operations
VITALCARE HEALTH SERVICES956721187manufacture(57439-003)

Revised: 6/2022
Document Id: e1815a46-4ee7-2786-e053-2a95a90a7094
Set id: e17eb920-f035-6530-e053-2995a90a798e
Version: 2
Effective Time: 20220615
 
Rotech Healthcare Inc