BD GasPak™ EZ C02 Gas Generating Pouch System

Basic Information

• Brand Name: BD GasPak™ EZ C02 Gas Generating Pouch System
• Primary DI: 30382902606841
• Version / Model: 260684
• Catalog Number: 260684
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 1
• Public Version Date: 2018-06-25
• Public Version Status: New
• Public Device Record Key: 13a2f51d-652f-4b17-96fe-0c276db3d852

Device Description

BD GasPak™ EZ C02 Gas Generating Pouch System

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: 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
KZJ	DEVICE, GAS GENERATING	Microbiology	866.2580	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43520	Atmospheric generation kit IVD	A pouch, unit, and/or other accessories intended to be used in combination to generate specific atmospheric conditions [e.g., increased carbon dioxide (CO2), reduced or depleted oxygen (AnO2)] as 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	30382902606841	GS1
Unit of Use	00382902606840	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius