CoFirm 10 Steam Biological Indicators

Basic Information

• Brand Name: CoFirm 10 Steam Biological Indicators
• Primary DI: 10732224000463
• Version / Model: CI10BI25
• Catalog Number: C10BI25
• Company Name: SPS Medical Supply Corp.
• Labeler DUNS: 194877072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2019-09-04
• Public Version: 3
• Public Version Date: 2023-08-11
• Public Version Status: Update
• Public Device Record Key: 64db9287-efff-4721-aa9e-d67b4b433b62

Device Description

Self-Contained Biological Indicator, 10 hour incubation

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: Yes
• PM Exempt: No
• 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
FRC	Indicator, biological sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50732224000461	GS1	case	4	In Commercial Distribution
Primary	10732224000463	GS1
Unit of Use	00732224000466	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature away from sterilants or other chemicals