DEVICE: Phoenix Diagnostics (00852676007049)

Device Identifier (DI) Information

Phoenix Diagnostics
3-221
In Commercial Distribution

PHOENIX DIAGNOSTICS, INC.
00852676007049
GS1

1
606814960 *Terms of Use
Wash/CD Pack 248 for Bayer / Ciba-Corning Blood Gas Systems
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
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).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JIX Calibrator, Multi-Analyte Mixture
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K902267 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 460 Milliliter
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Device Record Status

b7f902d9-4a2f-4e53-aeca-2aca1cf0a7a5
March 30, 2020
4
August 12, 2017
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
5086558310
sales@phoenixdiagnostics.com
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