CoaguChek XS PT strips 4625315160

GUDID 00365702128101

Roche Diagnostics GmbH

Home-use/point-of-care coagulation analyser IVD, battery-powered

• Primary Device ID: 00365702128101
• NIH Device Record Key: b8fdba64-c825-4f08-ba45-611167ac3383
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoaguChek XS PT strips
• Version Model Number: 4625315160
• Catalog Number: 4625315160
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365702128101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060978

FDA Product Code

• GJS: TEST, TIME, PROTHROMBIN

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: 2016-09-20

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