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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
Freestanding patient positioner, reusable FDA UDI
Device Name
Neo-Natal Sandbag Positioner: 8"L x 1-1/2"W x 1"T FDA UDI
Model / Reference
GP592 FDA UDI
Description
Neo-Natal Sandbag Positioner: 8"L x 1-1/2"W x 1"T FDA UDI

Identifiers

Catalog Number
GP592 FDA UDI
Primary DI / UDI-DI
10810087351691 FDA UDI
FDA Product Code
PRN FDA UDI
GMDN Term
Freestanding patient positioner, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5680 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: Freestanding patient positioner, reusable

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

Similar devices

Also classified as Freestanding patient positioner, reusable.

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 31c1909f-c911-48cd-aaae-fd6a8b0ef59c 34 fields · synced Jun 8, 2026