FDA.reportPublic FDA data

BED COVER-4X36X88-CEN PRO PLUS MAT TOP-P

Primary DI
00840828196291
Brand
BED COVER-4X36X88-CEN PRO PLUS MAT TOP-P
Company
CURBELL MEDICAL PRODUCTS, INC.
Model
BMC-43688-CENPROPLUSTOP-PC
Catalog number
30685
Device description
BED COVER-4X36X88-CEN PRO PLUS MAT TOP-P
Published
2026-04-08
Public version status
New
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
00840828196291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840828196291008408281962918408281962910840828196291

GMDN Terms#

Term, Definition table
TermDefinition
Bed mattress/cover setA collection of devices designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and which may help to promote therapeutic postures. It typically consists of a bed mattress, mattress overlay/cover and wedge-shaped cushion which are typically made of knitted polyester, polyurethane foam, buckwheat husk or combinations of materials. This is a reusable device after appropriate cleaning.

Contacts#

Phone, Email table
PhoneEmail
18002357500mwinter@curbell.com

Regulatory Flags#

DUNS number
796452311
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840828196444GEN4 INTERACTIVE421384U-0709008307402026-05-19
00840828196451GEN4 PLUS, DIRECT ACCESS5C050U-P10000288307442026-05-19
00840828196406GEN4 INTERACTIVE42119CU-0104018307102026-05-07
00840828196413GEN4 PLUS, DIRECT ACCESS5C330U-Z10300011307092026-05-07
00840828196420800 S37,JE,BE,2L,790,BE ON 6&8BIC-19C0-A08-8307022026-05-07
00840828196437GEN4 INTERACTIVE437370U-0119728307152026-05-07
00840828196369GEN4 INTERACTIVE45331E-S14059F306952026-04-23
00840828196376GEN4 INTERACTIVE43719FU-0103018307002026-04-23
00840828196383GEN4 PLUS, DIRECT ACCESS5C430U-Z3020000F307012026-04-23
00840828196390GEN4 PLUS, DIRECT ACCESS5C422U-Z12700028307062026-04-23
00840828196338CALLCD,800,180,NO LOGO,WIRED FOR CACC180-986306882026-04-14
00840828196345RESPONDER 5, INTERACTIVE5I41JU-562427A306892026-04-14
00840828196352RESPONDER 5, INTERACTIVE5I41UU-801002A306922026-04-14
00840828196321SURELOCK, CURBELL/PHILIPS, BLUE, 10 PK989803209691306232026-04-09
00840828196284GEN4 INTERACTIVE410370E-0104468306862026-04-08
00840828196246RESPONDER 5, INTERACTIVE5I414U-164031A306742026-04-01
00840828196253GEN4 INTERACTIVE45422U-S103028306802026-04-01
00840828196260GEN4 PLUS, DIRECT ACCESS5C19DU-Z15900178306762026-04-01
00840828196277GEN4 INTERACTIVE425331U-0150518306512026-04-01
00840828196222GEN4 PLUS, DIRECT ACCESS5C240U-Z1000000C306632026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
00850045714543Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-10-20