Thermo Scientific GlucoCrush™

GUDID 00845275006551

Fisher Diagnostics

Glucose IVD, reagent

• Primary Device ID: 00845275006551
• NIH Device Record Key: a15773a2-01bd-4bf6-9bd3-a5904b41a131
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Scientific GlucoCrush™
• Version Model Number: B2495-1A
• 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: 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	00845275006551 [Primary]
GS1	00845275006643 [Unit of Use]
GS1	00845275006735 [Package]; Package: [4 Units]; In Commercial Distribution

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 GlucoCrush™]

• 00845275006629: B2495-9A
• 00845275006612: B2495-7A
• 00845275006605: B2495-6A
• 00845275006599: B2495-5A
• 00845275006582: B2495-4A
• 00845275006575: B2495-3A
• 00845275006568: B2495-2A
• 00845275006551: B2495-1A
• 00845275006544: B2495-10A