Airgas Healthcare

Basic Information

• Brand Name: Airgas Healthcare
• Primary DI: 00819601020061
• Version / Model: Device Gas
• Catalog Number: Biological Atmosphere
• Company Name: AIRGAS USA LLC
• Labeler DUNS: 831996595
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-01
• Public Version: 1
• Public Version Date: 2018-09-03
• Public Version Status: New
• Public Device Record Key: 8ed2faf4-bc57-49af-afd9-7693c64a41fa

Device Description

Used to grow and sustain anaerobic, aerobic bacteria, or cultures in a biological incubator.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BXK	Gas, Calibration (Specified Concentration)	Anesthesiology	868.6400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16335	Anaerobic chamber	An airtight chamber filled with a mixture of oxygen-free gases designed to allow laboratory personnel to culture specimens, observe growth, perform subsequent testing, and incubate cultures under anaerobic conditions. It is typically in the form of a framework covered with a thick, transparent, flexible polyvinyl chloride (PVC) with glove boxes (i.e., sleeve-like ports placed in the sides of the chamber that terminate in thick gloves) which allow the operators to operate and manipulate the object placed in the chamber without compromising it atmosphere.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819601020061	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 52 Degrees Celsius