FDA.reportPublic FDA data

SelectAir Max

Primary DI
00817365020914
Brand
SelectAir Max
Company
Moxi Enterprises, LLC
Model
SAIM0101
Device description
SELECT AIR MAX 240 MATTRESS REPL SYSTEM
Published
2016-08-05
Public version status
Update
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
00817365020914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817365020914008173650209148173650209140817365020914

GMDN Terms#

Term, Definition table
TermDefinition
Low-air-loss bedA mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116972382
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
00817365021423eMotionFM-MOX1006FM-MOX10062022-11-01
00817365021683SelectAirFC-MXSTUS5FC-MXSTUS52023-03-29
00817365021690SelectAirFC-MXMXUS5FC-MXMXUS52023-03-29
00817365021706SelectAirFC-MXHYUS5FC-MXHYUS52023-03-29
00817365021355SelectAirSA54NFLGCOVSA54NFLGCOV2022-11-04
00817365021522SelectAirSASTDCOVSPSASTDCOVSP2022-11-04
00817365021591SelectAirSASTDNFLGCOVSASTDNFLGCOV2022-11-04
00817365021812SelectAirFIRSTCSHEETFIRSTCSHEET2022-11-04
00817365021829SelectAirPM-SACV398408PM-SACV3984082022-11-04
00817365021836SelectAirPM-SACV398008PM-SACV3980082022-11-04
00817365021843SelectAirSA2PCCOV-NHTSA2PCCOV-NHT2022-11-04
00817365021850SelectAirPM-CVSA398410PM-CVSA3984102022-11-04
00817365021867SelectAirPM-CVSA398010PM-CVSA3980102022-11-04
00817365021874SelectAirPM-CVSA428410PM-CVSA4284102022-11-04
00817365021898SelectAirPM-CVSA428010PM-CVSA4280102022-11-04
00817365021904SelectAirPM-CVSA488410PM-CVSA4884102022-11-04
00817365021911SelectAirPM-CVSA488010PM-CVSA4880102022-11-04
00817365021928SelectAirPM-CVSA548410PM-CVSA548410 2022-11-04
00817365021935SelectAirPM-CVSA548010PM-CVSA5480102022-11-04
00817365021942SelectAirPM-CVSA608410PM-CVSA6084102022-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
00810055884230ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884247ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884254ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884261ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884278ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884285ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884292ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884308ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884315ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884322ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884339ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884346ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884353ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884360ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
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
00190885000070MatrixMidtown Investments, LLCFNM2023-01-28
00190885000087MatrixMidtown Investments, LLCFNM2023-01-28
00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
00190885000100MatrixMidtown Investments, LLCFNM2023-01-28