CoaguChek XS Patient Self Testing Care Kit 4837738001

GUDID 00365702125100

Roche Diagnostics GmbH

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

• Primary Device ID: 00365702125100
• NIH Device Record Key: 96cb2595-2a9e-488a-b8a1-90a244683568
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoaguChek XS Patient Self Testing Care Kit
• Version Model Number: 4837738001
• Catalog Number: 4837738001
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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 1 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00365702125100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062925

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

On-Brand Devices [CoaguChek XS Patient Self Testing Care Kit]

• 00365702125100: 4837738001
• 04015630945689: 03666794001