DEVICE: STAT PROFILE (00385480356381)
Device Identifier (DI) Information
STAT PROFILE
CCX
In Commercial Distribution
35638
NOVA BIOMEDICAL CORPORATION
CCX
In Commercial Distribution
35638
NOVA BIOMEDICAL CORPORATION
STAT PROFILE CRITICAL CARE XPRESS CONTROL 1,2,3
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? |
---|---|---|---|---|
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 [?] |
---|---|
K061830 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Handling Environment Temperature: between 24 and 26 Degrees Celsius |
Special Storage Condition, Specify: Do not freeze |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
11ca469e-ee96-4fc7-b6a3-5ad4cc2eb50b
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 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:
00385489356382
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com