BIOlogical52

Basic Information

• Brand Name: BIOlogical52
• Primary DI: 10850065007820
• Version / Model: 3702
• Catalog Number: 3702
• Company Name: HF ACQUISITION CO. LLC
• Labeler DUNS: 045657305
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-11
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 82857b76-1f38-4352-b156-5272136d9c35

Device Description

Biological Indicator Mail-in Monitoring Test Strips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: Yes
• 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
Primary	10850065007820	GS1
Package	50850065007828	GS1	Master Case	10	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dispose of expired spore strips in a landfill or incinerator.
• Type: Special Storage Condition, Specify
• Special Conditions: Sterilize expired spore strips and culture media before disposal.
• Type: Special Storage Condition, Specify
• Special Conditions: Store away from sterilizing units and other heat sources or chemical products.
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place.