DEVICE: Hemochron Whole Blood Microcoagulation System (10711234103012)
Device Identifier (DI) Information
Hemochron Whole Blood Microcoagulation System
J103
In Commercial Distribution
J103
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
J103
In Commercial Distribution
J103
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
APTT Cuvette - 45 test cuvettes/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? |
---|---|---|---|---|
55982 | Activated partial thromboplastin time (APTT) 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 quantitative measurement of the activated partial thromboplastin time (APTT) of a clinical specimen.
|
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 [?] |
---|---|
K940401 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 35 and 46 Degrees Fahrenheit |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ab67d142-7e5c-47bb-9588-32fec44d942c
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:
00711234103015
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