CoaguChek XS Patient Self Testing Care Kit

Basic Information

• Brand Name: CoaguChek XS Patient Self Testing Care Kit
• Primary DI: 04015630945689
• Version / Model: 03666794001
• Catalog Number: 03666794001
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 251487ff-9776-4511-a45f-de28ec6873c2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GJS	Test, Time, Prothrombin	Hematology	864.7750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56887	Cancer antigen 15-3 (CA15-3) IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of cancer antigen 15-3 (CA15-3), a marker commonly associated with breast cancer, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630945689	GS1

Premarket Submissions

Submission Number	Supplement Number
K062925	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 40 Degrees Celsius