AccessGUDID - DEVICE: BCS® System Cuvette Rotors (00842768014444)

GUDID

Device Identifier (DI) Information

Brand Name: BCS® System Cuvette Rotors
Version or Model: 10446524
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OVIP15
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768014444
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 126
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: The BCS Cuvette Rotor is part of the BCS-XP system.

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?
56689	Coagulation analyser IVD, laboratory	An electrically-powered automated or semi-automated 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKP	INSTRUMENT, COAGULATION, AUTOMATED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970431	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 2 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4f2122d2-e5a8-45f7-8a66-4129f11884c0
Public Version Date: September 16, 2022
Public Version Number: 6
DI Record Publish Date: October 31, 2017