DEVICE: HemosIL Factor X Deficient Plasma (10 X 1 mL) (08426950491385)
Device Identifier (DI) Information
HemosIL Factor X Deficient Plasma (10 X 1 mL)
00020010000
In Commercial Distribution
00020010000
INSTRUMENTATION LABORATORY COMPANY
00020010000
In Commercial Distribution
00020010000
INSTRUMENTATION LABORATORY COMPANY
HemosIL Factor X Deficient Plasma (10 X 1 mL)
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? |
---|---|---|---|---|
56034 | Coagulation factor X IVD, kit, clotting |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor X in a clinical specimen, using a clotting method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GJT | PLASMA, COAGULATION FACTOR DEFICIENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K031122 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Unopened deficient plasma is stable until the expiration date shown on the vial when stored at 2-8°C. |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
50c20abf-ac69-4e95-b55a-96b68cdf65bd
July 14, 2021
5
September 23, 2016
July 14, 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:
18426950491382
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-678-0710
techsupport.na@werfen.com
techsupport.na@werfen.com