FDA.reportPublic FDA data

LUMEX

Primary DI
M368LCM48801
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
LCM4880
Device description
Lumex Select Convertible, Alternating Pressure Mattress
Published
2019-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
M368LCM48801PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattressA mattress-like device consisting of an arrangement of alternating-pressure air cells designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It is connected to an alternating-pressure pump (not included) which provides the inflation/deflation control. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers) patients, patients with disabilities, or patients with low body fat.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

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