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Ameritus

FDA UDI

Class II (US FDA UDI)

by Kentec Medical, Inc.

Identity

Trade Name
Ameritus FDA UDI
Generic Name
Environmental sensor FDA UDI
Device Name
ACCU-TEMP PROBE #230 FOR USE W/OHMEDA w/120P probe cover FDA UDI
Model / Reference
230 FDA UDI
Description
ACCU-TEMP PROBE #230 FOR USE W/OHMEDA w/120P probe cover FDA UDI

Identifiers

Catalog Number
230 FDA UDI
Primary DI / UDI-DI
10817522010038 FDA UDI
510(k) Number
K960080 FDA UDI
FDA Product Code
FMT FDA UDI
GMDN Term
Environmental sensor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Environmental sensor

Ameritus by Kentec Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Environmental sensor.

Cleared under the same submission

K960080 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kentec Medical, Inc.

Sources (1)

  • FDA UDI e3f8af2c-e091-4d73-b3fc-aa13ca392836 36 fields · synced May 30, 2026