Oxygen
FDA Label NDC 52200-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Home Care Medical Llc for the product Oxygen (NDC 52200-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding certificate of analysis, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 (Home Cm O2 Coa Tag Front)

Coa Front (Home Cm O2 Coa Tag Front)

Coa Back (Home Cm O2 Coa Tag Back)

Coa Back (Home Cm O2 Coa Tag Back)


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