Inito

FDA UDI

Class II (US FDA UDI)

by Samplytics Technologies Private Limited

Identity

Trade Name: Inito FDA UDI
Generic Name: Intermittent electronic patient thermometer FDA UDI
Device Name: InTemp Basal Thermometer is a device used to intermittently measure the body temperature of a person. FDA UDI
Model / Reference: FDTH-V0-13 FDA UDI
Description: InTemp Basal Thermometer is a device used to intermittently measure the body temperature of a person. FDA UDI

Identifiers

Primary DI / UDI-DI: 08908018929370 FDA UDI
FDA Product Code: SDV 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

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

MRI Safety

MR Unsafe FDA UDI

Category: Intermittent electronic patient thermometer

Inito by Samplytics Technologies Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Samplytics Technologies Private Limited

Sources (1)

FDA UDI b35bd589-ece3-466f-a943-b5577fc23893 33 fields · synced May 30, 2026