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Cool-Tip

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Cool-Tip FDA UDI
Generic Name
General-purpose patient temperature probe, single-use FDA UDI
Device Name
Ablation Remote Temperature Probe FDA UDI
Model / Reference
RTP20 FDA UDI
Description
Ablation Remote Temperature Probe FDA UDI

Identifiers

Primary DI / UDI-DI
10884521802445 FDA UDI
FDA Product Code
NEY FDA UDI
GMDN Term
General-purpose patient temperature probe, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 20 Centimeter FDA UDI

Category: General-purpose patient temperature probe, single-use

Cool-Tip by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose patient temperature probe, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 3d07f4f1-36b2-48f7-ad99-4196fd931a57 36 fields · synced May 30, 2026