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Device Explorer · FDA GUDID · GMDN 37455

Waterproof bed mattress cover, reusable

A device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It can be

US‑registered devices396in commercial distribution
Companies13labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Casco Manufacturing Solutions, Inc.19148%
Moxi Enterprises, Llc6015%
Trinity Guardion, Inc.5414%
Curbell Medical Products, Inc.297%
Vive Health Llc174%
Invacare Corporation103%
Medline Industries, Inc.103%
Dynarex Corporation92%

Top labelers

CompanyDevicesShare
Casco Manufacturing Solutions, Inc.19148%
Moxi Enterprises, Llc6015%
Trinity Guardion, Inc.5414%
Curbell Medical Products, Inc.297%
Vive Health Llc174%
Invacare Corporation103%
Medline Industries, Inc.103%
Dynarex Corporation92%
Drive Devilbiss Healthcare62%
Icp Medical, Llc41%
Frontier Therapeutics Inc31%
Kreg Medical Inc.21%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Repose Companion CoverRepose Trolley Mattress CoverRepose Blue Cushion over EU 45cmCOVERLET WITH ZIPPERSoteria Bed BarrierSoteria Mattress BarrierSoteria Neonatal Mattress BarrierSoteria Pediatric Mattress BarrierInvacare® Softform Premier Foam Mattress CoverInvacare Solace Mattress CoverInvacare EssentialsSTR COVER-4X30X76-2T-VELCRO BWSTR MATTRESS-4X26X76-2T-VELCRO BWSTR COVER-4X26X76-2T-VELCRO BWBED COVER-VERSACARE-8X35.5X86-POLYCARBSTR CVR-5X30X76-2 TAPER-SM3A/F MAT-POLYC

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FMWCover, Mattress (Medical Purposes)167
FMWCOVER, MATTRESS (MEDICAL PURPOSES)142
QTVMattress And Bed Deck Cover (Medical Purposes)47
IKYMATTRESS, FLOTATION THERAPY, NON-POWERED32
FNMMattress, air flotation, alternating pressure5
FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE5

GMDN & GCC registration

  • GMDN code 37455 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 0% · OTC 9%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 4Width (Inch) · 4Length (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many waterproof bed mattress cover, reusable products are registered in the US?

396 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Waterproof bed mattress cover, reusable", from 13 companies. The largest labeler is Casco Manufacturing Solutions, Inc. with 48% of records.

Which FDA product codes apply?

FMW (Cover, Mattress (Medical Purposes)), FMW (COVER, MATTRESS (MEDICAL PURPOSES)), QTV (Mattress And Bed Deck Cover (Medical Purposes)), IKY (MATTRESS, FLOTATION THERAPY, NON-POWERED)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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