SPORVIEW STEAM BI TEST PACK-25 CNTRLS

Basic Information

• Brand Name: SPORVIEW STEAM BI TEST PACK-25 CNTRLS
• Primary DI: 10732224720989
• Version / Model: SBT-025
• Catalog Number: SBT-025
• Company Name: SPS Medical Supply Corp.
• Labeler DUNS: 194877072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-15
• Public Version: 4
• Public Version Date: 2021-10-11
• Public Version Status: Update
• Public Device Record Key: 5777abfb-4b54-438f-be2f-fbca5a9cd533

Device Description

Single use test pack designed to routinely challenge the steam sterilization process in both gravity and prevacuum steam sterilizers

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
Package	50732224720987	GS1	box	25	In Commercial Distribution
Primary	10732224720989	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity