BT Sure

Basic Information

• Brand Name: BT Sure
• Primary DI: 10815773020264
• Version / Model: AY759X1
• Catalog Number: AY759X1
• Company Name: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
• Labeler DUNS: 791530061
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-28
• Public Version: 1
• Public Version Date: 2019-07-08
• Public Version Status: New
• Public Device Record Key: bfa0a6eb-af6c-4e13-80e5-4bb528638253

Device Description

BT Sure - Steam - Biological Indicators, 5 count

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: Yes
• 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	10815773020264	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 40 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit