Accuflexpro+ Oral Thermometer (blue)

FDA UDI

Class II (US FDA UDI)

by A.M.G. Médicale Inc

Identity

Trade Name: ACCUFLEXPRO+ ORAL THERMOMETER (BLUE) FDA UDI
Generic Name: Intermittent electronic patient thermometer FDA UDI
Device Name: Accuflex®Pro+ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and make it easy to prevent the spread of contamination among patients. This digital thermometer provides quick and accurate readings healthcare professionals can count on. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds for oral readings Washable for easy cleaning Gentle-flex tip for patient comfort Easy to use with large screen for better nighttime visibility Display in Celsius or Fahrenheit Auto shut-off feature Memory recall / display of last 30 readings Individually packaged, includes storage case Anti-Bacterial additive Convenient colour codes – blue for oral and red for rectal FDA UDI
Model / Reference: 016-648 FDA UDI
Description: Accuflex®Pro+ single-patient digital thermometers can help to prevent the risk of cross-contamination, nosocomial infections and make it easy to prevent the spread of contamination among patients. This digital thermometer provides quick and accurate readings healthcare professionals can count on. Accurate within ± 0.1°C in the 35°C to 42°C range Fast response time: 10 seconds for oral readings Washable for easy cleaning Gentle-flex tip for patient comfort Easy to use with large screen for better nighttime visibility Display in Celsius or Fahrenheit Auto shut-off feature Memory recall / display of last 30 readings Individually packaged, includes storage case Anti-Bacterial additive Convenient colour codes – blue for oral and red for rectal FDA UDI

Identifiers

Catalog Number: 016-648 FDA UDI
Primary DI / UDI-DI: 00057565166481 FDA UDI
510(k) Number: K163518 FDA UDI
FDA Product Code: FLL FDA UDI
GMDN Term: Intermittent electronic patient thermometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intermittent electronic patient thermometer

Accuflexpro+ Oral Thermometer (blue) by A.M.G. Médicale Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Intermittent electronic patient thermometer.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: A.M.G. Médicale Inc

Sources (1)

FDA UDI ce5d18e0-8410-4fc9-9924-83c098da500e 35 fields · synced Jun 8, 2026

Accuflexpro+ Oral Thermometer (blue)

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)