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Electrolyte 54

FDA UDI

Class II (US FDA UDI)

by Radiometer Medical ApS

Identity

Trade Name
Electrolyte 54 FDA UDI
Generic Name
Transcutaneous blood gas monitor sensor FDA UDI
Device Name
Electrolyte for tc sensor 54 FDA UDI
Model / Reference
905-866 FDA UDI
Description
Electrolyte for tc sensor 54 FDA UDI

Identifiers

Catalog Number
905-866 FDA UDI
Primary DI / UDI-DI
05700699058669 FDA UDI
FDA Product Code
LKD FDA UDI
LPP FDA UDI
KLK FDA UDI
DPZ FDA UDI
DQA FDA UDI
GMDN Term
Transcutaneous blood gas monitor sensor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2480 FDA UDI
868.2500 FDA UDI
870.2710 FDA UDI
870.2700 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

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Transcutaneous blood gas monitor sensor

Electrolyte 54 by Radiometer Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous blood gas monitor sensor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radiometer Medical ApS

Sources (1)

  • FDA UDI 24698bcc-d7a1-406d-b1bb-24e757ff701e 36 fields · synced May 30, 2026