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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
MEDLINE FDA UDI
Generic Name
External circulating-air core temperature regulation system control unit, heating/cooling FDA UDI
Device Name
COMFORTTEMP BLOWER TRIAL ONLY FDA UDI
Model / Reference
CTBLOWERTRL FDA UDI
Description
COMFORTTEMP BLOWER TRIAL ONLY FDA UDI

Identifiers

Catalog Number
CTBLOWERTRL FDA UDI
Primary DI / UDI-DI
10197344131624 FDA UDI
510(k) Number
K231211 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
External circulating-air core temperature regulation system control unit, heating/cooling 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: External circulating-air core temperature regulation system control unit, heating/cooling

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-air core temperature regulation system control unit, heating/cooling.

Cleared under the same submission

K231211 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI 577fbb4c-bbcb-48a2-b358-a3b90060b0b9 37 fields · synced Jun 6, 2026