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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 control unit FDA UDI
Device Name
Accessory Hose Set for CSZ Unit FDA UDI
Model / Reference
ST-H1 FDA UDI
Description
Accessory Hose Set for CSZ Unit FDA UDI

Identifiers

Catalog Number
6201-0001 FDA UDI
Primary DI / UDI-DI
10615089620109 FDA UDI
FDA Product Code
ILO FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system control unit 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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Circulating-fluid localized thermal therapy system control unit

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 control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Adroit Medical Systems, Inc.

Sources (1)

  • FDA UDI 8802914b-3045-4160-97f3-3ff0f0fffc45 35 fields · synced Jun 9, 2026