AccessGUDID - DEVICE: Coatest Heparin (08426950088196)

GUDID

Device Identifier (DI) Information

Brand Name: Coatest Heparin
Version or Model: 25 5539 63
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25 5539 63
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950088196
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: Coatest 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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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 [?]
K833891	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
Special Storage Condition, Specify: When kept at 2-8°C the sealed reagents are stable until expiry date printed on the label. Avoid contamination by microorganisms in opened vials.
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: 23b502af-4621-4c70-a6db-6cbf64746577
Public Version Date: July 13, 2021
Public Version Number: 6
DI Record Publish Date: September 23, 2016