Consulting Wallah › Device Explorer › Mobility, beds & patient care › Waterproof bed mattress cover, single-use
Device Explorer · FDA GUDID · GMDN 35181

Waterproof bed mattress cover, single-use

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. This is a

US‑registered devices57in commercial distribution
Companies5labelers on GUDID
Single‑use84%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Cardinal Health, Inc.4579%
Medline Industries, Inc.916%
Domico Med-Device, Llc12%
Welmed Inc.12%
Ehob Inc12%

Top labelers

CompanyDevicesShare
Cardinal Health, Inc.4579%
Medline Industries, Inc.916%
Domico Med-Device, Llc12%
Welmed Inc.12%
Ehob Inc12%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Domico Med-DeviceWelmed, Inc.WingsSimplicityNOVAPLUSWAFFLEMedline

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

FDA product codes

CodeNameDevices
KMEBEDDING, DISPOSABLE, MEDICAL59
FNMMATTRESS, AIR FLOTATION, ALTERNATING PRESSURE9
BWNTable And Attachments, Operating-Room1
PUIDrape, Surgical, Exempt1
EYQGARMENT, PROTECTIVE, FOR INCONTINENCE1
IKYMattress, Flotation Therapy, Non-Powered1

GMDN & GCC registration

  • GMDN code 35181 · non‑implantable
  • Single‑use 84% · sterile 0% · Rx‑only 0% · OTC 95%
  • 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) · 61Width (Inch) · 59

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

How many waterproof bed mattress cover, single-use products are registered in the US?

57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Waterproof bed mattress cover, single-use", from 5 companies. The largest labeler is Cardinal Health, Inc. with 79% of records.

Which FDA product codes apply?

KME (BEDDING, DISPOSABLE, MEDICAL), FNM (MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE), BWN (Table And Attachments, Operating-Room), PUI (Drape, Surgical, Exempt)

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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