DEVICE: Hemochron Whole Blood Coagulation System (10711234202098)
Device Identifier (DI) Information
Hemochron Whole Blood Coagulation System
R-PRT200K
In Commercial Distribution
R-PRT200K
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
R-PRT200K
In Commercial Distribution
R-PRT200K
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Kaolin Protamine Response Test 40 tubes/box
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
30595 | Multiple coagulation factor IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KFF | Assay, Heparin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K010193 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
25e1a87d-7ce3-427b-9a09-181d0eda3190
August 31, 2022
5
September 22, 2016
August 31, 2022
5
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00711234202091
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