ONE-CARE Non-Contact Infrared Thermometer

FDA UDI

Class II (US FDA UDI)

by MediVena, LLC

Identity

Trade Name: ONE-CARE Non-Contact Infrared Thermometer FDA UDI
Generic Name: Infrared patient thermometer, skin FDA UDI
Device Name: The ONE-CARE Non-Contact Infrared Thermometer HTD8813C is a battery-operated, non-contact infrared thermometer with two modes for multi-measurement: body mode for measuring forehead temperature and surface mode for measuring the temperature of objects such as rooms, milk, food, water, etc. FDA UDI
Model / Reference: 4020 ONE-CARE Non-Contact Infrared Thermometer HTD8813C FDA UDI
Description: The ONE-CARE Non-Contact Infrared Thermometer HTD8813C is a battery-operated, non-contact infrared thermometer with two modes for multi-measurement: body mode for measuring forehead temperature and surface mode for measuring the temperature of objects such as rooms, milk, food, water, etc. FDA UDI

Identifiers

Catalog Number: 4020 FDA UDI
Primary DI / UDI-DI: 00810008217986 FDA UDI
FDA Product Code: FLL FDA UDI
GMDN Term: Infrared patient thermometer, skin 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

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

Yes

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Dimensions & Sizes

Size: Length — 138 Millimeter FDA UDI
Width — 95 Millimeter FDA UDI
Height — 40 Millimeter FDA UDI

Category: Infrared patient thermometer, skin

ONE-CARE Non-Contact Infrared Thermometer by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared patient thermometer, skin.

TytoHome — TYTO CARE LTD · Class II
ALPHAMED — Shenzhen Urion Technology Co., Ltd. · Class II
Diagnostix™ — American Diagnostic Corporation · Class II
Famidoc — FAMIDOC USA, INC. · Class II
Sinocare Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
Famidoc — Famidoc Technology Company Limited · Class II
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 II	Pending data

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Manufacturer

Manufacturer: MediVena, LLC

Sources (1)

FDA UDI 68054441-9ad2-49d9-b765-9ba7255307ce 36 fields · synced Jun 8, 2026