DEVICE: Alfa Wassermann (00857969006372)
Device Identifier (DI) Information
Alfa Wassermann
E1-9
In Commercial Distribution
E1-9
ALFA WASSERMANN, INC.
E1-9
In Commercial Distribution
E1-9
ALFA WASSERMANN, INC.
STARLYTE V Fluid Pack
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
59238 | Ion selective electrode (ISE) reference solution IVD, reagent |
A substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
|
Active | false |
52867 | Multiple electrolyte IVD, calibrator |
A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
No Product Codes |
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 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
f754baaf-2a2d-4ffb-b1d1-7403e0716362
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
973-852-0158
HKatz@AlfaWassermannUS.com
HKatz@AlfaWassermannUS.com