AccessGUDID - DEVICE: CoaguChek XS Professional Use Care Kit (00365702126107)

GUDID

Device Identifier (DI) Information

Brand Name: CoaguChek XS Professional Use Care Kit
Version or Model: 4837975001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4837975001
Company Name: Roche Diagnostics GmbH

Primary DI Number: 00365702126107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56687	Home-use/point-of-care coagulation analyser IVD, battery-powered	A battery-powered instrument intended to be used by a layperson in the home or similar environment, or by health professionals at the point-of-care, for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GJS	TEST, TIME, PROTHROMBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060978	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 1 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e9702845-c1c4-42bc-9429-91453e1dfb66
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016