FDA.reportPublic FDA data

Select Protect

Primary DI
00817365020747
Brand
Select Protect
Company
MOXI ENTERPRISES, LLC
Model
SAPROTECTSTD
Device description
SELECT PROTECT STANDARD SYSTEM (COVER AND BOLSTERS)
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00817365020747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817365020747008173650207478173650207470817365020747

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

Regulatory Flags#

DUNS number
958807575
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00817365021850SelectAirSA39COV-NHTSA39COV-NHT2022-11-04
00817365021867SelectAirSA39NOFTCOVSA39NOFTCOV2022-11-04
00817365021874SelectAirSA42COV-NHT SA42COV-NHT 2022-11-04
00817365021898SelectAirSA42NOFTCOVSA42NOFTCOV2022-11-04
00817365021904SelectAirSA48COV-NHT SA48COV-NHT 2022-11-04
00817365021911SelectAirSA48NOFTCOVSA48NOFTCOV2022-11-04
00817365021928SelectAirSA54COV-NHT SA54COV-NHT 2022-11-04
00817365021935SelectAirSA54NOFTCOVSA54NOFTCOV2022-11-04
00817365021942SelectAirSA60COV-NHT SA60COV-NHT 2022-11-04
00817365021959SelectAirSA60NOFTCOVSA60NOFTCOV2022-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850045714581Soteria Mattress BarrierTrinity Guardion, Inc.FMW2026-03-10
00840828195898BED COVER-4X36X84-PROGRESSA PULM TOP-PCCURBELL MEDICAL PRODUCTS, INC.FMW2026-01-20
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
00850045714536Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-08-18
00840828194433BED COVER 8X36X86 P500 VC STEP DECK - PCCURBELL MEDICAL PRODUCTS, INC.FMW2025-08-11
00818323020403SuresVIVE HEALTH LLCFMW2025-07-09
00818323020410SuresVIVE HEALTH LLCFMW2025-07-09