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K-3oem EZ-AIRE

FDA UDI

Class II (US FDA UDI)

by Kap Medical

Identity

Trade Name
K-3oem EZ-AIRE FDA UDI
Generic Name
Low-air-loss bed FDA UDI
Device Name
Pulsating, Low Air Loss, Mattress System, 80" x 36" x 8". FDA UDI
Model / Reference
TopWaveMS FDA UDI
Description
Pulsating, Low Air Loss, Mattress System, 80" x 36" x 8". FDA UDI

Identifiers

Catalog Number
TopWaveMS FDA UDI
Primary DI / UDI-DI
00817012031485 FDA UDI
FDA Product Code
IOQ FDA UDI
GMDN Term
Low-air-loss bed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5170 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-3oem EZ-AIRE 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 3d5353b9-a38a-4537-a46c-6d6d35e807ac 35 fields · synced May 30, 2026