← Back to catalogue

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
OHMEDA GIRAFFE OMNI-BED COMPATIBLE TEMP.PROBE w/120P probe cover FDA UDI
Model / Reference
232 FDA UDI
Description
OHMEDA GIRAFFE OMNI-BED COMPATIBLE TEMP.PROBE w/120P probe cover FDA UDI

Identifiers

Catalog Number
232 FDA UDI
Primary DI / UDI-DI
10817522010045 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kentec Medical, Inc.

Sources (1)

  • FDA UDI 5536e9ee-4ced-4b05-b6e6-dbd90ee37c31 36 fields · synced Jun 8, 2026