OXYGEN - oxygen gas 
Home Care Medical LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Certificate of Analysis

CERTIFICATE OF ANALYSIS   UNIT NUMBER___________ SERIAL NUMBER___________ AMOUNT_________________INS, LBS, LITERS, CU FT.

USP TESTS

TEST      ID      ODOR      ASSAY

LIMITS   OK      NONE         99.2%

RESULT __           _____          _____

FOR CUSTOMERS USE TO DOCUMENT TESTS PERFORMED ON THIS VESSEL IF TESTING WAS NOT WITNESSED

TEST      ID      ODOR      ASSAY

LIMITS   OK      NONE         99.2%

RESULT __           _____          _____

CUSTOMER WITNESSED TESTS? _YES  ___NO

OXYGEN PURITY AND ID TESTED WITH A __________ ANALYZER MODEL NO_________   ABSENCE OF ODOR CONFIRMED BY THE OLIFACTORY METHOD _________  SUPPLIERS SIGNATURE_____________________ DATE____________  CUSTOMERS SIGNATURE_____________DATE____________   ENTER LOT NUMBER AND PLACE STICKER HERE________________ EXPIRATION DATE__________



MEDICAL GASES LIQUID OXYGEN U.S.P. DELIVERY TAG  FILLED BY: (PLEASE STAMP LOCATION ADDRESS OR PLACE LABEL BELOW)   THIS VESSEL CONTAINS OXYGEN U.S.P. (SEE REVERSE SIDE FOR TEST RESULTS)  OXYGEN PRODUCED BY THE AIR LIQUEFACTION METHOD


COA FRONT

COA BACK


OXYGEN 
oxygen gas
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52200-001
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52200-001-0121 L in 1 DEWAR
2NDC:52200-001-0231 L in 1 DEWAR
3NDC:52200-001-0336 L in 1 DEWAR
4NDC:52200-001-0441 L in 1 DEWAR
5NDC:52200-001-0545 L in 1 DEWAR
6NDC:52200-001-0646 L in 1 DEWAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved medical gas01/01/1981
Labeler - Home Care Medical LLC (043751499)
Registrant - Home Care Medical LLC (043751499)
Establishment
NameAddressID/FEIBusiness Operations
Home Care Medical LLC043751499manufacture

Revised: 1/2010
Document Id: 6b1bffe0-00bc-4273-bc09-d81155c31059
Set id: 21d92c49-246c-4fd4-b5e3-12d45efc343d
Version: 1
Effective Time: 20100101
 
Home Care Medical LLC