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Welkins

FDA UDI

Class II (US FDA UDI)

by Welkins, LLC

Identity

Trade Name
Welkins FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system FDA UDI
Device Name
Temperature Management System FDA UDI
Model / Reference
TRS-2 FDA UDI
Description
Temperature Management System FDA UDI

Identifiers

Catalog Number
161000 FDA UDI
Primary DI / UDI-DI
B9301610000 FDA UDI
510(k) Number
K121720 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5900 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Circulating-fluid localized thermal therapy systemExternal circulating-fluid core temperature regulation system control unit, cooling-only

Welkins by Welkins, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-fluid core temperature regulation system control unit, cooling-only.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Welkins, LLC

Sources (1)

  • FDA UDI ac1160a2-1809-4f8b-bb57-dc6e725688ee 36 fields · synced May 30, 2026