K-3 Aire-Zone

FDA UDI

Class II (US FDA UDI)

by Kap Medical

Identity

Trade Name: K-3 AIRE-ZONE FDA UDI
Generic Name: Low-air-loss bed FDA UDI
Device Name: Pulsation, True Low Air Loss 10" High 42" Wide Mattress, Bariatric UK System FDA UDI
Model / Reference: K-3-UK-B42 FDA UDI
Description: Pulsation, True Low Air Loss 10" High 42" Wide Mattress, Bariatric UK System FDA UDI

Identifiers

Catalog Number: K-3-UK-B42 FDA UDI
Primary DI / UDI-DI: 00817012027570 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Low-air-loss bed

The K-3 AIRE-ZONE is a high-quality, mains electricity (AC-powered) bed that utilizes pulsation and true low air loss to provide controlled tissue pressure management during patient confinement in a hospital acute care department or nursing home. Its unique design features an inflatable mattress with connected pillows, a compressor, filters, and a built-in control unit. This device is designed for patients requiring bariatric treatment, offering a safe and effective solution for managing respiratory issues. With its advanced technology and user-friendly interface, the K-3 AIRE-ZONE is ideal for healthcare professionals and patients alike. It is also compliant with regulatory standards and has been certified by medical authorities. Available for purchase online or through authorized distributors.

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Dolphin Fluid Immersion Simulation — Joerns Healthcare · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Kap Medical

Sources (1)

FDA UDI 7c715666-649c-46c8-ad4b-43d3c3a6be59 35 fields · synced Jun 25, 2026