Skip to content

Application set Neonatal 0607120

by Radiometer Basel AG

Application set Neonatal 0607120 is a Class II device made by Radiometer Basel AG, listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05700693095226), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05700693095226 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Application set Neonatal
Generic name
Transcutaneous blood gas monitor sensor
Model / Ref / Catalog
0607120
Primary DI / UDI-DI
05700693095226
FDA product code
KLK, LKD
GMDN term
Transcutaneous blood gas monitor sensor
Device class
Class II
Regulation number
868.2500, 868.2480
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code KLK (Monitor, oxygen, cutaneous, for infant not under gas anesthesia).

Other devices from Radiometer Basel AG

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)