FDA.reportPublic FDA data

"Mattress Gap Filler, 6"" x 6"" x 42"" "

Primary DI
00840117342156
Brand
"Mattress Gap Filler, 6"" x 6"" x 42"" "
Company
Dynarex Corporation
Model
10574
Published
2025-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840117342095PackageGS16In Commercial Distribution
00840117342156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117342095008401173420958401173420950840117342095
00840117342156008401173421568401173421560840117342156

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
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117309210Resp-O2 Suction Tubing Combo Pack, Non-Sterile321002021-04-22
00840117309234Resp-O2 Suction Connecting Tubing, Non-Conductive321032021-04-22
00840117309258Resp-O2 Suction Connecting Tubing, Non-Conductive321042021-04-22
00840117309272Resp-O2 Suction Connecting Tubing, Non-Conductive321062021-04-22
00840117309296Resp-O2 Suction Connecting Tubing, Non-Conductive321072021-04-22
00840117309371Resp-O2 Suction Connecting Tubing, Non-Conductive321112021-04-22
00840117309395Resp-O2 Suction Connecting Tubing, Non-Conductive321122021-04-22
00840117313651Resp-O2 Suction Connecting Tubing, Non-Conductive321052021-04-22
00840117309418Resp-O2 Yankauer Suction Handle, Bulb Tip, Vented,321202022-05-10
00840117309432Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321212022-05-10
00840117309456Resp-O2 Yankauer Suction Handle, Straight Tip, Vented321222022-05-10
00840117309319Resp-O2 Suction Connecting Tubing, Non-Conductive321082022-05-09
00840117309326Resp-O2 Suction Connecting Tubing, Non-Conductive321092022-05-09
00840117309357Resp-O2 Suction Connecting Tubing, Non-Conductive321102022-05-09
00840117309494Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321262022-05-09
00840117309470Resp-O2 Yankauer Suction Handle, Straight Tip, Non-Vented321232022-04-21
00840117313675Resp-O2 Yankauer Suction Handles, Bulb Tip, Non-Vented321252022-04-21
00840117313699Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321272022-04-21
00840117313712Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321282022-04-21
00840117321748Resp-O2 Suction Connecting Tubing, Non-Sterile321012022-04-21

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