FDA.reportPublic FDA data

KEUZ

Primary DI
00850051333165
Brand
KEUZ
Company
Mp2g Diagnostic Corp
Model
KEUZ Alternating-Pressure Bed Mattress overlay sys
Device description
Bed-type Medical Air Cushion Wave-Motion of Block Shape
Published
2023-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051333165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051333165008500513331658500513331650850051333165

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress overlay systemAn assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
048991263
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850051333271GAESCA"Gaesca Steel Rollator 18"" (Red Color)"2025-03-03
00850051333288GAESCA"Gaesca Wheelchair for overweight people - removab2025-03-03
00850051333295GAESCA"Gaesca Transportation Wheelchair 22"" Width"2025-03-03
00850051333301GAESCA"Gaesca Transportation Wheelchair 24"" Width"2025-03-03
00850051333073GAESCAGaesca Standard Wheelchair armrest footrest remova2023-04-27
00850051333080GAESCAGaesca Standard Wheelchair Armrest and Footrest re2023-04-27
00850051333097GAESCAGaesca Standard Basic Portable Wheelchair 220 lbs/2023-04-27
00850051333264GAESCAGaesca Aluminium Foldable Walker with Wheels2023-05-31
00850051333240GAESCA"Gaesca Steel Foldable Rollator 8"" PVC Castor Whe2023-05-05
00850051333257GAESCA"Gaesca Steel Foldable Rollator 8"" PVC Castor Whe2023-05-05
00850051333004GAESCAGaesca Aluminium Elbow Crutches Standard (Pair)2023-05-04
00850051333011GAESCAGaesca Aluminium Elbow Crutches Gray (Pair)2023-05-04
00850051333028GAESCAGaesca Aluminium Elbow Crutches Blue (Pair)2023-05-04
00850051333035GAESCAGaesca Aluminium Elbow Crutches Black (Pair)2023-05-04
00850051333042GAESCAGaesca Aluminium Basic Crutches S2023-04-27
00850051333059GAESCAGaesca Aluminium Basic Crutches M2023-04-27
00850051333066GAESCAGaesca Aluminium Basic Crutches L2023-04-27
00850051333103GAESCA"Gaesca Aluminium Foldable Rollator 8"" PVC Castor2023-04-27
00850051333110GAESCA"Gaesca Aluminium Foldable Rollator 8"" PVC Castor2023-04-27
00850051333127GAESCAGaesca Aluminium Basic Walker Foldable2023-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876192011TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-09
04719876190048TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190215TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190482TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190499TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876191991TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192004TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192202TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192219TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
G771PDA91003680Pro-Daptive SensorCell Flotation SurfaceLEVISENSE MEDICAL, INC.FNM2026-06-09
00817012031874K-2oem ALT-AIRE+KAP MEDICALFNM2026-05-29
00817012031904K-4 D3XKAP MEDICALFNM2026-05-29
00817012031911K-4 D3XKAP MEDICALFNM2026-05-29
04719893356434WellellWellell Inc.FNM2026-04-20
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338436Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
04719893356922WellellWellell Inc.FNM2026-03-20
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
00023601033093CAREX HEALTH BRANDSDrive Devilbiss HealthcareFNM2024-06-13
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-04-16
H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-02-14
00190885000049MatrixMidtown Investments, LLCFNM2023-01-28
00190885000056MatrixMidtown Investments, LLCFNM2023-01-28
00190885000063MatrixMidtown Investments, LLCFNM2023-01-28
00190885000001MatrixMidtown Investments, LLCFNM2023-01-27
00190885000018MatrixMidtown Investments, LLCFNM2023-01-27
00190885000025MatrixMidtown Investments, LLCFNM2023-01-27