BT Sure AY759X8

GUDID 10815773020257

BT Sure - Steam - Biological Indicator, 100 count

THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC

Biological sterilization indicator

• Primary Device ID: 10815773020257
• NIH Device Record Key: 5f60e40e-9f2a-4c25-9294-ba3dea18668d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BT Sure
• Version Model Number: AY759X8
• Catalog Number: AY759X8
• Company DUNS: 791530061
• Company Name: THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-984-3766
• Email: Service.led.marietta@thermofisher.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 70 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815773020257 [Primary]

FDA Product Code

• FRC: Indicator, Biological Sterilization Process

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-08
• Device Publish Date: 2019-06-28

On-Brand Devices [BT Sure]

• 10815773020264: BT Sure - Steam - Biological Indicators, 5 count
• 10815773020257: BT Sure - Steam - Biological Indicator, 100 count
• 10815773020240: BT Sure - Steam - Biological Indicators, 100 count