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PSCS Coolant

FDA UDI

Class II (US FDA UDI)

by Paxman Coolers Limited

Identity

Trade Name
PSCS Coolant FDA UDI
Generic Name
Scalp cooling system, hair loss FDA UDI
Device Name
A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system. FDA UDI
Model / Reference
1L FDA UDI
Description
A consumable component of the Paxman Scalp Cooling System (PSCS) used as the cooling solution that is circulated within the system. FDA UDI

Identifiers

Catalog Number
300-16-01 FDA UDI
Primary DI / UDI-DI
B5611LCOOLANT0 FDA UDI
510(k) Number
K163484 FDA UDI
K173032 FDA UDI
FDA Product Code
PMC FDA UDI
GMDN Term
Scalp cooling system, hair loss FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4360 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Scalp cooling system, hair loss

PSCS Coolant by Paxman Coolers Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Scalp cooling system, hair loss.

Cleared under the same submission

K163484 also covers:

K173032 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paxman Coolers Limited

Sources (1)

  • FDA UDI 13408cb0-bad8-48f6-a895-b73cb13da693 36 fields · synced Jun 8, 2026