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Device Explorer · FDA GUDID · GMDN 35254

General-purpose patient temperature probe, single-use

A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a pati

US‑registered devices439in commercial distribution
Companies40labelers on GUDID
Single‑use94%of device records
Sterile41%labelled sterile
Prescription38%Rx‑only share
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Share of device records

Unimed Medical Supplies, Inc.12228%
Deroyal Industries, Inc.8319%
Icu Medical, Inc.4510%
Sourcemark, Llc.266%
Novamed-Usa Inc.184%
Measurement Specialties, Inc.143%
Shenzhen Launch Electrical Co., Ltd123%
Airlife Finland Oy123%

Top labelers

CompanyDevicesShare
Unimed Medical Supplies, Inc.12228%
Deroyal Industries, Inc.8319%
Icu Medical, Inc.4510%
Sourcemark, Llc.266%
Novamed-Usa Inc.184%
Measurement Specialties, Inc.143%
Shenzhen Launch Electrical Co., Ltd123%
Airlife Finland Oy123%
Covidien Lp113%
Drägerwerk Ag & Co. Kgaa102%
Genesee Biomedical, Inc.82%
Beijing Choice Electronic Technology Co., Ltd.61%

Company = labeler of record on GUDID. 40 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SINO-KFDKLaunchUnimedMED-LINKCHOICEMMEDTecothermDisposable Skin Temperature ProbesDIRECT SUPPLY Attendant Tympanic Thermometer ProBreathing Circuit for use with AutoBreath InfantThermoTrace Core (5pcs)ThermoTrace_Peripheral_5pcsSpu Skin Temp Probe Ped 3.0mSpu Skin Temp Probe Ped 1.6mSpu Skin Temp Probe Adult 3.0mSpu GP Temp Probe Ped 3.0m

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FLLThermometer, Electronic, Clinical213
FLLThermometer, electronic, clinical91
FMTWARMER, INFANT RADIANT40
BZTStethoscope, Esophageal, With Electrical Conductors24
FMTWarmer, Infant Radiant22
BZTSTETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS22

GMDN & GCC registration

  • GMDN code 35254 · non‑implantable
  • Single‑use 94% · sterile 41% · Rx‑only 38% · OTC 5%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Catheter Gauge (French) · 9Length (Millimeter) · 8Outer Diameter (Millimeter) · 5Length (Centimeter) · 4

Use these as the dimensions to specify in a tender line.

How many general-purpose patient temperature probe, single-use products are registered in the US?

439 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General-purpose patient temperature probe, single-use", from 40 companies. The largest labeler is Unimed Medical Supplies, Inc. with 28% of records.

Which FDA product codes apply?

FLL (Thermometer, Electronic, Clinical), FLL (Thermometer, electronic, clinical), FMT (WARMER, INFANT RADIANT), BZT (Stethoscope, Esophageal, With Electrical Conductors)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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