FDA.reportPublic FDA data

Reconstituted Air

Manufacturer
Helget Gas Products | Helget Gas Products, Inc.
Effective date
2025-12-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 21:48:40

Label at a glance#

ProductReconstituted Air
Active ingredientOXYGEN
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AIR, COMPRESSED USP

UN1002

DO NOT REMOVE THIS LABEL

Medical Air, USP

Rx only. WARNING: Administration of Medical Air may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Medical Air and is familiar with the indications, effects, dosages, methods, and frequency, and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken. WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. SUPPORTS COMBUSTION. Obtain, read and follow all safety instructions before use. Use a back flow preventive device in the piping. Mixture of Oxygen USP and Nitrogen NF. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. 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: 132259-10-0 DO NOT REMOVE THIS PRODUCT LABEL.

HELGET GAS PRODUCTS, 4211 S. 102ND STREET, OMAHA, NE 68127 866-814-1554 air 2025air 2025

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52086-020-01Reconstituted Air665 L in 1 CYLINDERGAS6652
52086-020-02Reconstituted Air6032 L in 1 CYLINDERGAS60322
52086-020-03Reconstituted Air8070 L in 1 CYLINDERGAS80702

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52086-02052086-020-01, 52086-020-02, 52086-020-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYGENS88TT14065ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Reconstituted AirRECONSTITUTED AIRHelget Gas Products436c1132-5ac9-b396-e063-6394a90adec42025-12-05Exact identifier
ndc (package): 52086-020-02
ndc (package): 52086-020-03
ndc (package): 52086-020-01
ndc (product): 52086-020
ndc11 (package): 52086002001
ndc11 (package): 52086002002
ndc11 (package): 52086002003
spl id: 45359819-2389-bd47-e063-6394a90add26
spl set id: 436c1132-5ac9-b396-e063-6394a90adec4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.