FDA.reportPublic FDA data

SelectAir

Primary DI
00817365021706
Brand
SelectAir
Company
Moxi Enterprises, LLC
Model
FC-MXHYUS5
Catalog number
FC-MXHYUS5
Device description
SelectAir G5 Hybrid Control Unit - US
Published
2023-03-29
Public version status
Update
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
00817365021706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817365021706008173650217068173650217060817365021706

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

Contacts#

Phone, Email table
PhoneEmail
314-771-5222info@moxiusa.com

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
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
00817365021959SelectAirPM-CVSA608010PM-CVSA6080102022-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H933M90068Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-09-25
00810055885695DOLPHIN FIS 48X82X10 AUTOVECTOR SYSTEM UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885701SYSTEM, DLPH PEDIATRIC CRIB, UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885718DOLPHIN FIS 35X82X10 AUTOVECTOR SYSTEM UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885725SYSTEM, 33X82X10, DOLPHIN PEDIATRIC, UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885732DOLPHIN 33.5 X 82 AUTOVECTOR SYSTEMJOERNS HEALTHCARE, LLCFNM2026-08-26
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