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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
Stretcher mattress FDA UDI
Device Name
Replacement Pad for Hill-Rom P8000 Stretcher: 4"T Pressure Relief Memory Foam with Fusion Conductive Covering. 30"W x 75"L x 4"T FDA UDI
Model / Reference
THR08-30-4PR FDA UDI
Description
Replacement Pad for Hill-Rom P8000 Stretcher: 4"T Pressure Relief Memory Foam with Fusion Conductive Covering. 30"W x 75"L x 4"T FDA UDI

Identifiers

Catalog Number
THR08-30-4PR FDA UDI
Primary DI / UDI-DI
10810087352322 FDA UDI
FDA Product Code
LWG FDA UDI
GMDN Term
Stretcher mattress 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: Stretcher mattress

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

Similar devices

Also classified as Stretcher mattress.

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 cd50e3f0-fe59-4f58-a41f-955a571faf8e 34 fields · synced Jun 8, 2026