← Back to catalogue

Soft-Temp

FDA UDI

Class II (US FDA UDI)

by Adroit Medical Systems, Inc.

Identity

Trade Name
Soft-Temp FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Device Name
Hyper-Hypothermia Patient Vest. FDA UDI
Model / Reference
ST-040 FDA UDI
Description
Hyper-Hypothermia Patient Vest. FDA UDI

Identifiers

Catalog Number
ST-040 FDA UDI
Primary DI / UDI-DI
10615089104005 FDA UDI
FDA Product Code
ILO FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system pack, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5720 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Circulating-fluid localized thermal therapy system pack, single-use

Soft-Temp by Adroit Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal therapy system pack, single-use.

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
Adroit Medical Systems, Inc.

Sources (1)

  • FDA UDI 9e639224-5c62-4037-a93c-cb3ce1015177 35 fields · synced Jun 9, 2026