DEVICE: Hemochron Whole Blood Coagulation System (10711234520048)
Device Identifier (DI) Information
Hemochron Whole Blood Coagulation System
HRS.RF
In Commercial Distribution
HRS.RF
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
HRS.RF
In Commercial Distribution
HRS.RF
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Hemochron Whole Blood Coagulation System - Hemochron Response Instrument Refurbished
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JPA | System, Multipurpose For In Vitro Coagulation Studies |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e3236dbc-1e87-4574-a9f1-c5bb0a630528
December 22, 2022
6
September 22, 2016
December 22, 2022
6
September 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-678-0710
ilsd_ra.na@werfen.com
ilsd_ra.na@werfen.com