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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, LARGE SIZE, INT FDA UDI
Model / Reference
60027 FDA UDI
Description
COOLING CAP SET, LARGE SIZE, INT FDA UDI

Identifiers

Catalog Number
60027 FDA UDI
Primary DI / UDI-DI
00382830009584 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

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Manufacturer

Manufacturer
Natus Medical Incorporated

Sources (1)

  • FDA UDI d8ae735d-1f69-4532-a968-7a7a0331ecb8 35 fields · synced May 31, 2026