← Back to catalogue

Cool-Cap

FDA UDI

Class III (US FDA UDI)

by Natus Medical Incorporated

Identity

Trade Name
Cool-Cap FDA UDI
Generic Name
External circulating-fluid core temperature regulation system control unit, cooling-only FDA UDI
Device Name
COOLING CAP SET, MEDIUM SIZE, INT FDA UDI
Model / Reference
60026 FDA UDI
Description
COOLING CAP SET, MEDIUM SIZE, INT FDA UDI

Identifiers

Catalog Number
60026 FDA UDI
Primary DI / UDI-DI
00382830009577 FDA UDI
PMA Number
P040025 FDA UDI
FDA Product Code
MXM FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system control unit, cooling-only FDA UDI

Classification

Device Class
Class III 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External circulating-fluid core temperature regulation system control unit, cooling-only

Cool-Cap by Natus Medical Incorporated — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-fluid core temperature regulation system control unit, cooling-only.

Cleared under the same submission

P040025 also covers:

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
Natus Medical Incorporated

Sources (1)

  • FDA UDI ab55b07e-1b6a-4082-9d99-612a677aa738 35 fields · synced Jun 8, 2026