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Dalton Xcell Air Mattress 2000

FDA UDI

Class II (US FDA UDI)

by Dalton Medical Corp.

Identity

Trade Name
DALTON XCELL AIR MATTRESS 2000 FDA UDI
Generic Name
Alternating-pressure bed mattress overlay, reusable FDA UDI
Device Name
DALTON XCELL AIR MATTRESS 2000 W/PUMP 50-60HZ, WT. LIMIT 300 LBS. FDA UDI
Model / Reference
PM-XCELL2000 FDA UDI
Description
DALTON XCELL AIR MATTRESS 2000 W/PUMP 50-60HZ, WT. LIMIT 300 LBS. FDA UDI

Identifiers

Primary DI / UDI-DI
00815027011942 FDA UDI
FDA Product Code
FNM FDA UDI
GMDN Term
Alternating-pressure bed mattress overlay, reusable 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

No

FDA UDI

Category: Alternating-pressure bed mattress overlay, reusable

Dalton Xcell Air Mattress 2000 by Dalton Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alternating-pressure bed mattress overlay, reusable.

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 668136b9-315f-4736-a75a-eab37537acc9 34 fields · synced May 30, 2026