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K-1 Derma-Kare

FDA UDI

Class II (US FDA UDI)

by Kap Medical

Identity

Trade Name
K-1 DERMA-KARE FDA UDI
Generic Name
Alternating-pressure bed mattress overlay system FDA UDI
Device Name
Alternating Pressure Raised Side Bolster Mattress, Standard UK System FDA UDI
Model / Reference
K-1-UK-RSB FDA UDI
Description
Alternating Pressure Raised Side Bolster Mattress, Standard UK System FDA UDI

Identifiers

Catalog Number
K-1-UK-RSB FDA UDI
Primary DI / UDI-DI
00817012026740 FDA UDI
FDA Product Code
FNM FDA UDI
GMDN Term
Alternating-pressure bed mattress overlay system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5550 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Alternating-pressure bed mattress overlay system

K-1 Derma-Kare by Kap Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alternating-pressure bed mattress overlay system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kap Medical

Sources (1)

  • FDA UDI 9c333670-82e7-4d6c-a4f6-ab68e3f59cbb 35 fields · synced May 30, 2026