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Coulmed

FDA UDI

Class I (US FDA UDI)

by Coulmed Products Group Llc

Identity

Trade Name
Coulmed FDA UDI
Generic Name
Gel-filled bed mattress overlay FDA UDI
Device Name
Bassinet Gel Pad (Neo-Natal), 26' x 12' x 1/2', per each FDA UDI
Model / Reference
GP120 FDA UDI
Description
Bassinet Gel Pad (Neo-Natal), 26' x 12' x 1/2', per each FDA UDI

Identifiers

Catalog Number
GP120 FDA UDI
Primary DI / UDI-DI
10810087351080 FDA UDI
FDA Product Code
LWG FDA UDI
GMDN Term
Gel-filled bed mattress overlay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 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

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Gel-filled bed mattress overlay

Coulmed by Coulmed Products Group Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gel-filled bed mattress overlay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coulmed Products Group Llc

Sources (1)

  • FDA UDI 349ed4e6-654f-4849-a0f8-249074c12224 34 fields · synced May 30, 2026