FDA.reportPublic FDA data

SelectAir

Primary DI
00817365021812
Brand
SelectAir
Company
Moxi Enterprises, LLC
Model
FIRSTCSHEET
Catalog number
FIRSTCSHEET
Device description
SelectAir First Care Overlay Sheet 36x80x4
Published
2022-11-04
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
FMWCover, Mattress (Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMWCover, Mattress (Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817365021812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817365021812008173650218128173650218120817365021812

GMDN Terms#

Term, Definition table
TermDefinition
Waterproof bed mattress cover, reusableA device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It can be laundered for cleaning. This is a reusable device.

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
Lot or batch
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
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
00840828196291BED COVER-4X36X88-CEN PRO PLUS MAT TOP-PCURBELL MEDICAL PRODUCTS, INC.FMW2026-04-08
00850045714581Soteria Mattress BarrierTrinity Guardion, Inc.FMW2026-03-10
00840828195898BED COVER-4X36X84-PROGRESSA PULM TOP-PCCURBELL MEDICAL PRODUCTS, INC.FMW2026-01-20
00850056748292FORWARD APLS Litter GuardINTEGRATED MEDCRAFT LLCFMW2026-01-15
07640178061446CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061736CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061828CT Table CoverPearl Technology AGFMW2025-12-17
07640178061835CT Table CoverPearl Technology AGFMW2025-12-17
07640178061842CT Table CoverPearl Technology AGFMW2025-12-17
07640178061927CT Table CoverPearl Technology AGFMW2025-12-17
07640178061934CT Table CoverPearl Technology AGFMW2025-12-17
07640178061941CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061958CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061965CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061972CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061989CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061996CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062009CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062016CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062023CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062030CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062047CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062054CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062061CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062184CT Table CoverPearl Technology AGFMW2025-12-17
07640178062191CT Table CoverPearl Technology AGFMW2025-12-17
07640178062207CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062214CT Table CoverPearl Technology AGFMW2025-12-17
00850056748315FORWARD APLS Surgery SoakerINTEGRATED MEDCRAFT LLCFMW2025-11-06
00850045714529Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-10-20