N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00816576028955
• Version / Model: CO2BAG
• Catalog Number: CO2BAG
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-12
• Public Version: 1
• Public Version Date: 2020-08-20
• Public Version Status: New
• Public Device Record Key: db7f21d8-e066-452f-b443-a3945fb76325

Device Description

Carbon Dioxide (CO2) Tablet Each tablet is individually sealed in a ten-pack foil pouch. Supplied with ten zip lock bags.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSK	Supplement, Culture Media	Microbiology	866.2450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42653	Atmospheric generation IVD, control	A material which is used to verify the performance of a product intended to be used to generate specific atmospheric conditions [e.g., increased carbon dioxide (CO2), reduced or depleted oxygen (AnO2)] to create an environment suitable for the cultivation, processing, or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816576028955	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius