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Device Explorer · FDA GUDID · GMDN 13116

Electronic thermometer probe cover

A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patien

US‑registered devices104in commercial distribution
Companies46labelers on GUDID
Single‑use82%of device records
Sterile4%labelled sterile
Prescription19%Rx‑only share
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Share of device records

Cardinal Health 200, Llc1010%
American Diagnostic Corp99%
Cardinal Health, Inc.77%
Welch Allyn, Inc.55%
Kaz Usa, Inc.55%
Medline Industries, Inc.55%
D-M-S Holdings, Inc.44%
Mckesson Medical-Surgical Inc.44%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc1010%
American Diagnostic Corp99%
Cardinal Health, Inc.77%
Welch Allyn, Inc.55%
Kaz Usa, Inc.55%
Medline Industries, Inc.55%
D-M-S Holdings, Inc.44%
Mckesson Medical-Surgical Inc.44%
Kang Ze Industrial Co., Ltd33%
Veridian Healthcare Llc33%
Medsource International Llc33%
Hopkins Uniform Company33%

Company = labeler of record on GUDID. 46 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

YiFangDisposable Thermometer Cover and SheathsActhermPolygreenTemp Probe Covers, 10 pcsBeurerBV MedicalUp & UpVERIDIANVeridianASP MEDICALMedSource Probe CoversHopkins Medical Products®MedSource Thermometer SheathsBISONHCS

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, Clinical67
FLLThermometer, electronic, clinical39
SDVClinical Electronic Thermometer5
FLKThermometer, Clinical Mercury3
KGXTape and bandage, adhesive3
FMTWARMER, INFANT RADIANT2

GMDN & GCC registration

  • GMDN code 13116 · non‑implantable
  • Single‑use 82% · sterile 4% · Rx‑only 19% · OTC 56%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many electronic thermometer probe cover products are registered in the US?

104 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electronic thermometer probe cover", from 46 companies. The largest labeler is Cardinal Health 200, Llc with 10% of records.

Which FDA product codes apply?

FLL (Thermometer, Electronic, Clinical), FLL (Thermometer, electronic, clinical), SDV (Clinical Electronic Thermometer), FLK (Thermometer, Clinical Mercury)

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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