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K-4 D³x

FDA UDI

Class II (US FDA UDI)

by Kap Medical

Identity

Trade Name
K-4 D³X FDA UDI
Generic Name
Low-air-loss bed FDA UDI
Device Name
Alternating Pressure with Low Air Loss Mattress System, 84" x 36" x 10" FDA UDI
Model / Reference
K-4MS36X84 FDA UDI
Description
Alternating Pressure with Low Air Loss Mattress System, 84" x 36" x 10" FDA UDI

Identifiers

Catalog Number
K-4MS36X84 FDA UDI
Primary DI / UDI-DI
00817012021066 FDA UDI
FDA Product Code
FNM FDA UDI
GMDN Term
Low-air-loss bed 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: Low-air-loss bed

K-4 D³x by Kap Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Low-air-loss bed.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kap Medical

Sources (1)

  • FDA UDI a1e4f2e2-8bb2-402f-b5d6-78b892120719 35 fields · synced May 30, 2026