DEVICE: IL PVP (08426950511519)
Device Identifier (DI) Information
IL PVP
00024001515
In Commercial Distribution
00024001515
INSTRUMENTATION LABORATORY COMPANY
00024001515
In Commercial Distribution
00024001515
INSTRUMENTATION LABORATORY COMPANY
PVP Set
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
52860 | Multiple blood gas/haemoximetry/electrolyte analyte IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJY | Multi-Analyte Controls, All Kinds (Assayed) |
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 2 and 8 Degrees Celsius |
Special Storage Condition, Specify: IL PVP ampoule levels 1 through 5 unopened are stable when stored at 15 - 25° C for up to 3 months or at 2 - 8° C until the expiration date shown on the label. DO NOT FREEZE |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0be2ff0f-379a-4e07-a16a-4f9abee564c0
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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-678-0710
techsupport.na@werfen.com
techsupport.na@werfen.com