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Protekt Aire

FDA UDI

Class II (US FDA UDI)

by Proactive Medical Products

Identity

Trade Name
Protekt Aire FDA UDI
Generic Name
Alternating-pressure bed mattress overlay system FDA UDI
Device Name
PROTEKT AIRE 4600 LOW AIR LOSS ALTERNATING PRESSURE MATTRESS SYSTEM FDA UDI
Model / Reference
84600 FDA UDI
Description
PROTEKT AIRE 4600 LOW AIR LOSS ALTERNATING PRESSURE MATTRESS SYSTEM FDA UDI

Identifiers

Catalog Number
84600 FDA UDI
Primary DI / UDI-DI
05060488570742 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 6 Inch FDA UDI
Width — 36 Inch FDA UDI
Length — 80 Inch FDA UDI

Category: Alternating-pressure bed mattress overlay system

Protekt Aire by Proactive Medical Products — 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
Proactive Medical Products

Sources (1)

  • FDA UDI aaea1831-bcd7-4d13-b8f0-714e039933a7 36 fields · synced May 29, 2026