AccessGUDID - DEVICE: Cuvettes for BFT // Analyzer (00842768012358)

GUDID

Device Identifier (DI) Information

Brand Name: Cuvettes for BFT // Analyzer
Version or Model: 10446541
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OVMN11
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768012358
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: The cuvettes serve coagulation tests as a reaction vessel.

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:	Yes
Prescription Use (Rx):	No
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?
56690	Coagulation analyser IVD, laboratory, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used 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 prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JPA	SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984501	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 688bf22d-2854-4e7d-bc11-d6625249fc26
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: October 31, 2017