AccessGUDID - DEVICE: Hemochron Whole Blood Microcoagulation System (10711234540039)

GUDID

Device Identifier (DI) Information

Brand Name: Hemochron Whole Blood Microcoagulation System
Version or Model: RPM-CD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RPM-CD
Company Name: ACCRIVA DIAGNOSTICS HOLDINGS, INC.

Primary DI Number: 10711234540039
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079299318 *Terms of Use

Device Description: Report Maker V6.01

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?
62540	Coagulation analyser IVD, point-of-care, line-powered	A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used exclusively at the point-of-care by medical professionals for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]. It may include spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.	Active	false
56689	Coagulation analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection.	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 [?]
K050016	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d98d0bdc-8239-4c23-bcb3-5d9c5402b339
Public Version Date: December 26, 2022
Public Version Number: 7
DI Record Publish Date: September 22, 2016