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Iob

FDA UDI

Class II (US FDA UDI)

by Iob Medical, Inc.

Identity

Trade Name
IOB FDA UDI
Generic Name
Circulating-air whole-body heating system control unit FDA UDI
Model / Reference
IOB-028 FDA UDI

Identifiers

Primary DI / UDI-DI
00850035767283 FDA UDI
510(k) Number
K190221 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Iob by Iob Medical, 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.

Cleared under the same submission

K190221 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Iob Medical, Inc.

Sources (1)

  • FDA UDI e16c8062-5629-4eef-b485-0de06a346a34 33 fields · synced May 30, 2026