Thermo Scientific Trutol™

GUDID 00845275004113

Fisher Diagnostics

Glucose IVD, reagent

• Primary Device ID: 00845275004113
• NIH Device Record Key: 3682669f-c43f-4da6-8669-6698b140732f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Scientific Trutol™
• Version Model Number: 401526P
• Company DUNS: 183998769
• Company Name: Fisher Diagnostics
• Device Count: 24
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845275004113 [Primary]
GS1	00845275006070 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032753

FDA Product Code

• MRV: Drink, Glucose Tolerance

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-19
• Device Publish Date: 2016-09-16

On-Brand Devices [Thermo Scientific Trutol™]

• 00845275004823: 401272PA
• 00845275004809: 401223PS
• 00845275004793: 401223PA
• 00845275004120: 401576P
• 00845275004113: 401526P
• 00845275004106: 401503P
• 00845275004090: 401272P
• 00845275004083: 401223P
• 00845275004076: 401207P
• 00845275004069: 401074P
• 00845275004052: 401025P
• 00845275004045: 401009P