AccessGUDID - DEVICE: Sonoclot® kACT Kit (B55880004001)

GUDID

Device Identifier (DI) Information

Brand Name: Sonoclot® kACT Kit
Version or Model: 800-0400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-0400
Company Name: SIENCO, INC.

Primary DI Number: B55880004001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 064039514 *Terms of Use

Device Description: The kACT Kit is an in vitro diagnostic test for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The kACT test is a kaolin activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The kACT kit is intended for high dose heparin management with or without aprotinin. The kACT test provides quantitative Onset/ACT and Clot Rate results with the Sonoclot Analyzer. The kACT test is not intended for platelet function monitoring. Each kACT Kit contains 100 lidded blue plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of kaolin and a magnetic stir bar.

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:	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?
55996	Multiple coagulation factor IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen, using a clotting method.	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 [?]
K952560	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: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0c6f222f-0326-42e5-88a9-21cea1d47d50
Public Version Date: July 27, 2021
Public Version Number: 1
DI Record Publish Date: July 19, 2021