BI-OK Steam Test-Pak w/ 10 Controls

Basic Information

• Brand Name: BI-OK Steam Test-Pak w/ 10 Controls
• Primary DI: 70818087012385
• Version / Model: 26921000
• Company Name: PROPPER MANUFACTURING COMPANY, INC.
• Labeler DUNS: 001483130
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2019-03-11
• Public Version: 1
• Public Version Date: 2019-03-19
• Public Version Status: New
• Public Device Record Key: 3fb9c781-db46-471f-97c5-bc64e9954ec8

Device Description

BI-OK Steam Test-Pak w/ 10 Controls

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: 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
Primary	70818087012385	GS1
Unit of Use	10818087012383	GS1

Premarket Submissions

Submission Number	Supplement Number
K903024	000