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Dalton Xcell Air Mattres

FDA UDI

Class II (US FDA UDI)

by Dalton Medical Corp.

Identity

Trade Name
DALTON XCELL AIR MATTRES FDA UDI
Generic Name
Air-filled bed mattress overlay FDA UDI
Device Name
XCELL AIR MATTRESS 2000. ADJUSTABLE LOW PRESSURE THERAPY PUMP AND MATTRESS SYSTEM. FDA UDI
Model / Reference
PM-XCELL2000 FDA UDI
Description
XCELL AIR MATTRESS 2000. ADJUSTABLE LOW PRESSURE THERAPY PUMP AND MATTRESS SYSTEM. FDA UDI

Identifiers

Primary DI / UDI-DI
00815027011836 FDA UDI
FDA Product Code
FNM FDA UDI
GMDN Term
Air-filled bed mattress overlay 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

No

FDA UDI

Category: Air-filled bed mattress overlay

Dalton Xcell Air Mattres by Dalton Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-filled bed mattress overlay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dalton Medical Corp.

Sources (1)

  • FDA UDI a877af25-d75f-4319-b4a7-7866a4ca0dbc 34 fields · synced May 30, 2026