AccessGUDID - DEVICE: Xprecia Stride™ Coagulation Analyzer (00630414025148)

GUDID

Device Identifier (DI) Information

Brand Name: Xprecia Stride™ Coagulation Analyzer
Version or Model: 11065584
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11065584
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414025148
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: The Xprecia Stride™ Coagulation System is intended for use by professional healthcare providers to provide an INR (InternationalNormalized Ratio) based on a Prothrobin time (PT) response for the monitoring of oral anticoagulation therapy with Warfarin.

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:	No
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?
62542	Coagulation analyser IVD, point-of-care, battery-powered	An exclusively battery-powered instrument intended to be used exclusively at the point-of-care by medical professionals 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)]. It may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGN	PLASMA, COAGULATION CONTROL
GJS	TEST, TIME, PROTHROMBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e6da5bc3-47c8-4e7b-944e-4b32693fa629
Public Version Date: October 21, 2024
Public Version Number: 7
DI Record Publish Date: March 01, 2017