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FDA Approval

Oxygen Helium Mixture

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Aero All Gas Company
DUNS: 004532065
Effective Date
May 25, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Helium(800 mL in 1 L)
Oxygen(200 mL in 1 L)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Aero All Gas Company

Aero All Gas Company

004532065

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Oxygen Helium Mixture

Product Details

NDC Product Code
10014-006
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
May 25, 2010
HeliumActive
Code: 206GF3GB41Class: ACTIBQuantity: 800 mL in 1 L
OxygenActive
Code: S88TT14065Class: ACTIBQuantity: 200 mL in 1 L
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