DEVICE: HemosIL UF Heparin Controls (08426950478683)
Device Identifier (DI) Information
HemosIL UF Heparin Controls
00020300300
In Commercial Distribution
00020300300
INSTRUMENTATION LABORATORY COMPANY
00020300300
In Commercial Distribution
00020300300
INSTRUMENTATION LABORATORY COMPANY
HemosIL UF Heparin Controls
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
56273 | Heparin anti-Xa IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative monitoring of heparin anticoagulant therapy by determining its ability to inhibit the activity of activated factor X (factor Xa) in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GNN | ANTISERA, NEUTRALIZATION, COXSACKIEVIRUS A 1-24, B 1-6 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K090209 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify: Unopened controls are stable until the expiration date shown on the vial when stored at 2-8°C. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
b121be90-0615-400e-870a-09d14478e514
July 13, 2021
5
September 23, 2016
July 13, 2021
5
September 23, 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:
18426950478680
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-678-0710
techsupport.na@werfen.com
techsupport.na@werfen.com