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Test Cartridge

FDA UDI

Class II (US FDA UDI)

by Edan Instruments, Inc.

Identity

Trade Name
Test Cartridge FDA UDI
Generic Name
Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE) FDA UDI
Model / Reference
BG8 FDA UDI

Identifiers

Primary DI / UDI-DI
06944413802872 FDA UDI
510(k) Number
K151978 FDA UDI
FDA Product Code
CHL FDA UDI
GMDN Term
Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE)

Test Cartridge by Edan Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE).

Cleared under the same submission

K151978 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edan Instruments, Inc.

Sources (1)

  • FDA UDI f7b99feb-2f01-4f1d-ae7f-9bbe4be5ed74 33 fields · synced May 30, 2026