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The First Years

FDA UDI

Class II (US FDA UDI)

by TOMY International, Inc.

Identity

Trade Name
The First Years FDA UDI
Generic Name
General-purpose patient temperature probe, reusable FDA UDI
Device Name
Multi-Use Digital Thermometer FDA UDI
Model / Reference
Y7078A8 FDA UDI
Description
Multi-Use Digital Thermometer FDA UDI

Identifiers

Catalog Number
Y7078A8 FDA UDI
Primary DI / UDI-DI
B268Y7078A80 FDA UDI
510(k) Number
K851146 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
General-purpose patient temperature probe, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose patient temperature probe, reusable

The First Years by TOMY International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose patient temperature probe, reusable.

Cleared under the same submission

K851146 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
TOMY International, Inc.

Sources (1)

  • FDA UDI 37cd6d27-8990-4093-b2db-162b092a180a 35 fields · synced Jun 8, 2026