DEVICE: Phoenix Diagnostics (00852676007049)
Device Identifier (DI) Information
Phoenix Diagnostics
3-221
In Commercial Distribution
PHOENIX DIAGNOSTICS, INC.
3-221
In Commercial Distribution
PHOENIX DIAGNOSTICS, INC.
Wash/CD Pack 248 for Bayer / Ciba-Corning Blood Gas Systems
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
52859 | Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator |
A material which is used to establish known points of reference for 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).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIX | Calibrator, Multi-Analyte Mixture |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K902267 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 460 Milliliter |
Device Record Status
b7f902d9-4a2f-4e53-aeca-2aca1cf0a7a5
March 30, 2020
4
August 12, 2017
March 30, 2020
4
August 12, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
01085267600704 | 6 | 00852676007049 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
5086558310
sales@phoenixdiagnostics.com
sales@phoenixdiagnostics.com