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Soft Air

FDA UDI

Class II (US FDA UDI)

by Adroit Medical Systems, Inc.

Identity

Trade Name
Soft Air FDA UDI
Generic Name
Circulating-air whole-body heating system control unit FDA UDI
Device Name
Blanket, Full Underbody FDA UDI
Model / Reference
A545 FDA UDI
Description
Blanket, Full Underbody FDA UDI

Identifiers

Catalog Number
1907-0001 FDA UDI
Primary DI / UDI-DI
10615089196208 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
Circulating-air whole-body heating system control unit 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Circulating-air whole-body heating system control unit

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

Similar devices

Also classified as Circulating-air whole-body heating 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 78da269f-39c7-47a8-b050-283a1428a1ca 35 fields · synced Jun 9, 2026