AccessGUDID - DEVICE: Sonoclot® NonActivated Kit (B55880004251)

GUDID

Device Identifier (DI) Information

Brand Name: Sonoclot® NonActivated Kit
Version or Model: 800-0425
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-0425
Company Name: SIENCO, INC.

Primary DI Number: B55880004251
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 064039514 *Terms of Use

Device Description: The Non-Activated Clotting Test Kit contains the necessary components for an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. It may be used with native whole blood, citrated whole blood, and plasma. The Non-Activated Kit may either be used as a non-activated clotting test or as a general use test with user provided activators. It is intended for customer designed hemostasis monitoring on the Sonoclot Analyzer. The Non-Activated cuvette allows for coagulation monitoring using tissue activation, thrombin activation, and other custom activators. Some of the applications for the Non-Activated test with the addition of customer determined reagents are monitoring of fibrin formation, fibrinolysis, hyperfibrinolysis and clot retraction. When used with the Sonoclot Analyzer System, the Non-Activated test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis. Each kit contains 100 lidded plastic cuvettes, 100 probes, and instructions for use. The cuvettes contain 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: 7feb0ebc-3f94-4de7-9261-41e93671ce08
Public Version Date: July 27, 2021
Public Version Number: 1
DI Record Publish Date: July 19, 2021