DEVICE: Hemochron Whole Blood Coagulation System (10711234101094)
Device Identifier (DI) Information
Hemochron Whole Blood Coagulation System
P214
In Commercial Distribution
P214
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
P214
In Commercial Distribution
P214
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
ACT Tubes 95 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? |
---|---|---|---|---|
55994 | Activated clotting time (ACT) 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 clotting time (ACT) of a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JBP | Activated Whole Blood Clotting Time |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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
7a183fe6-787c-4820-aec1-e6d2e1d0c66f
August 31, 2022
4
September 22, 2016
August 31, 2022
4
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:
00711234101097
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