AccessGUDID - DEVICE: Berichrom® Heparin LMW Calibrator (00842768006845)

GUDID

Device Identifier (DI) Information

Brand Name: Berichrom® Heparin LMW Calibrator
Version or Model: 10445987
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OPCA03
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768006845
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 6
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin

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):	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?
56196	Heparin anti-Xa IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen.	Active	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 [?]
K083159	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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 74210c63-d080-456c-a5c1-f9a1d7d4f511
Public Version Date: September 05, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016