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Phoenix Diagnostics

FDA UDI

Class II (US FDA UDI)

by Phoenix Diagnostics, Inc.

Identity

Trade Name
Phoenix Diagnostics FDA UDI
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator FDA UDI
Device Name
Wash/CD Pack 248 for Bayer / Ciba-Corning Blood Gas Systems FDA UDI
Model / Reference
3-221 FDA UDI
Description
Wash/CD Pack 248 for Bayer / Ciba-Corning Blood Gas Systems FDA UDI

Identifiers

Primary DI / UDI-DI
00852676007049 FDA UDI
510(k) Number
K902267 FDA UDI
FDA Product Code
JIX FDA UDI
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 460 Milliliter FDA UDI

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

Phoenix Diagnostics by Phoenix Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator.

Cleared under the same submission

K902267 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Phoenix Diagnostics, Inc.

Sources (1)

  • FDA UDI b7f902d9-4a2f-4e53-aeca-2aca1cf0a7a5 37 fields · synced May 30, 2026