Thermo Scientific Infinity™

GUDID 00845275003444

Fisher Diagnostics

Angiotensin converting enzyme (ACE) IVD, calibrator

• Primary Device ID: 00845275003444
• NIH Device Record Key: 728c8c1a-1fcd-431f-82de-1be200419d7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Scientific Infinity™
• Version Model Number: TR85201
• Company DUNS: 183998769
• Company Name: Fisher Diagnostics
• Device Count: 6
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-528-0494
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845275003444 [Primary]
GS1	00845275006292 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041657

FDA Product Code

• JIS: Calibrator, Primary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Thermo Scientific Infinity™]

• 00845275003444: TR85201
• 00845275003420: TR85056
• 00845275003383: TR70121
• 00845275003352: TR66056
• 00845275003314: TR60901
• 00845275003239: TR50001
• 00845275003031: TR35121
• 00845275002751: TR25421
• 00845275002423: TR15421
• 00845275002409: TR15221
• 00845275001082: 1265250
• 00845275000429: TR66901
• 00845275000351: TR12421
• 00845275000047: TR28321