I-MED Non-Contact Infrared digital Clinical Thermometer

FDA UDI

Class I (US FDA UDI)

by I-Med Pharma Inc

Identity

Trade Name: I-MED Non-Contact Infrared digital Clinical Thermometer FDA UDI
Generic Name: Infrared patient thermometer, skin FDA UDI
Device Name: Ideal for quickly detecting elevated body temperature using a non-contact design. Measures body temperature from 90°F to 109°F (32.0°C to 42.5°C) without contact. Accurate to 0.5°F (0.3°C) with 0.1°F/°C resolution. Adjustable alarm alerts user visually and audibly when temperature exceeds programmed limit. Optimum measurement distance of 2 in. to 5.9-in. (5 to 15 cm). FDA UDI
Model / Reference: 5700 FDA UDI
Description: Ideal for quickly detecting elevated body temperature using a non-contact design. Measures body temperature from 90°F to 109°F (32.0°C to 42.5°C) without contact. Accurate to 0.5°F (0.3°C) with 0.1°F/°C resolution. Adjustable alarm alerts user visually and audibly when temperature exceeds programmed limit. Optimum measurement distance of 2 in. to 5.9-in. (5 to 15 cm). FDA UDI

Identifiers

Catalog Number: 5700 FDA UDI
Primary DI / UDI-DI: 00622554057004 FDA UDI
FDA Product Code: FQZ FDA UDI
FLL FDA UDI
GMDN Term: Infrared patient thermometer, skin FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.2900 FDA UDI
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Infrared patient thermometer, skin

I-MED Non-Contact Infrared digital Clinical Thermometer by I-Med Pharma Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Sinocare Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
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DR.TALBOT'S Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
Berrcom — Guangzhou Berrcom Medical Device Co., Ltd · Class II

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 I	Pending data

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Manufacturer

Manufacturer: I-Med Pharma Inc

Sources (1)

FDA UDI cf5ac084-d8cf-4455-81de-c703fd63d45c 35 fields · synced Jun 8, 2026