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FifthPulse

FDA UDI

Class I (US FDA UDI)

by Jeg & Sons Inc.

Identity

Trade Name
FifthPulse FDA UDI
Generic Name
Cold/cool therapy gel FDA UDI
Device Name
Color Changing Medical Cooling Gel Patch FDA UDI
Model / Reference
10 Pack FDA UDI
Description
Color Changing Medical Cooling Gel Patch FDA UDI

Identifiers

Catalog Number
FMN100535 FDA UDI
Primary DI / UDI-DI
00810084939406 FDA UDI
FDA Product Code
OMW FDA UDI
GMDN Term
Cold/cool therapy gel FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5710 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

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cold/cool therapy gel

FifthPulse by Jeg & Sons Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cold/cool therapy gel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jeg & Sons Inc.

Sources (1)

  • FDA UDI 54b8910f-65f9-4e1f-b036-0b2b3368c6c3 34 fields · synced Jun 6, 2026