AccessGUDID - DEVICE: Berichrom® Heparin (00842768012945)

GUDID

Device Identifier (DI) Information

Brand Name: Berichrom® Heparin
Version or Model: 10446620
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OWLD11
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768012945
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Determination of heparin activity in plasma and for the monitoring of heparin therapy

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?
56195	Heparin anti-Xa IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the quantitative detection of heparin by measuring its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen, using a chromogenic method. The assay is typically used to monitor anticoagulation therapy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KFF	ASSAY, HEPARIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K925200	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: dace88f1-8609-4ba6-8111-ce7aa7c610b7
Public Version Date: September 05, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016