FDA.reportPublic FDA data

PAT-ALA-AP

Primary DI
G530PATLALAP480
Brand
PAT-ALA-AP
Company
Nu Dimension Tech Ventures LLC
Model
48
Catalog number
PAT-LAL-AP-48
Device description
Low Airloss Alternating Pressure Air Mattress 48 inch
Published
2023-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
G530PATLALAP480PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress systemAn assembly of devices consisting of an alternating-pressure bed mattress (inflation-patterned air cells with or without foam component) and a dedicated electric 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
131179203
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G530CZAPM360CZ-APM36CZ-APM-362023-11-06
G530CZAPM420CZ-APM42CZ-APM-422023-11-06
G530CZAPM480CZ-APM48CZ-APM-492023-11-06
G530CZAPMP360CZ-APM-P36CZ-APM-P-362023-11-06
G530CZAPMP420CZ-APM-P42CZ-APM-P-422023-11-06
G530CZAPMP480CZ-APM-P48CZ-APM-P-482023-11-06
G530PATLAL360PAT-LAL36PAT-LAL-36 2023-11-06
G530PATLAL420PAT-LAL42PAT-LAL-422023-11-06
G530PATLAL480PAT-LAL48PAT-LAL-482023-11-06
G530PATLALAP360PAT-ALA-AP36PAT-LAL-AP-36 2023-11-06
G530PATLALAP420PAT-ALA-AP42PAT-LAL-AP-42 2023-11-06
G530PATLRT360PAT-LRT36PAT-LRT-362023-11-06
G530PATLRT420PAT-LRT42PAT-LRT-422023-11-06
G530PATLRT480PAT-LRT48PAT-LRT-482023-11-06
G530TITAN10000TITAN1000TITAN10002023-11-06
G530TITAN3600E0TITAN3600ETITAN3600E2023-11-06
G530TITAN42000TITAN4200TITAN42002023-11-06
G530TITAN48000TITAN4800TITAN48002023-11-06
G530TITAN54000TITAN5400TITAN54002023-11-06
TITANLB600TITANLB6002023-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226442016ViveVIVE HEALTH LLCFNM2026-08-19
00810226442023ViveVIVE HEALTH LLCFNM2026-08-19
00810226442030ViveVIVE HEALTH LLCFNM2026-08-19
00850076421106ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421113ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421120ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421137ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
H93359076Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-07-27
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
00841447116745Invacare MA500X4280MINVACARE CORPORATIONFNM2026-07-01
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