CoaguChek XS Pro Kit 05448964001

GUDID 04015630945733

Roche Diagnostics GmbH

Coagulation analyser IVD, point-of-care, battery-powered

• Primary Device ID: 04015630945733
• NIH Device Record Key: 3465f405-2363-43cb-abc5-6c45d41214ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoaguChek XS Pro Kit
• Version Model Number: 05448964001
• Catalog Number: 05448964001
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630945733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093460

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: 4
• Public Version Date: 2021-01-22
• Device Publish Date: 2016-09-24

On-Brand Devices [CoaguChek XS Pro Kit]

• 00365702398108: 5530199160
• 04015630945733: 05448964001