FDA.reportPublic FDA data

ProCure

Primary DI
10840330704820
Brand
ProCure
Company
Twin Med, LLC
Model
PCEPBB-B
Catalog number
PCEPBB-B
Device description
"ProComfortMax Extra Protective Bariatric Briefs Size B Up to 100"" "
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840330704824PackageGS14In Commercial Distribution
10840330704820PrimaryGS10
00840330704823Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084033070482430840330704824
1084033070482010840330704820
00840330704823008403307048238403307048230840330704823

GMDN Terms#

Term, Definition table
TermDefinition
Adult nappyA disposable undergarment (a nappy or diaper) composed of absorbent material and worn between the legs used to collect urine and faeces from an incontinent adult patient. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
804-776-2873xx@xx.xx

Regulatory Flags#

DUNS number
107071289
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840330705599ProCurePCSDPN500PCSDPN5002026-05-12
10840330706695ProCurePCHF3005PCHF30052026-05-07
10840330706701ProCurePCHF3006PCHF30062026-05-07
10840330702574ProCurePCGBMB60PPCGBMB60P2026-05-06
10840330702581ProCurePCGBMB60WPCGBMB60W2026-05-06
10840330702598ProCurePCGBMB72PPCGBMB72P2026-05-06
10840330702604ProCurePCGBPB72PPCGBPB72P2026-05-06
10840330704882ProCurePCFS200PCFS2002026-05-06
10840330702291ProCurePC136PC1362026-05-05
10840330702307ProCurePC137PC1372026-05-05
10840330702314ProCurePC138PC1382026-05-05
10840330704363ProCurePC167PC1672026-05-05
10840330706558ProCurePCDT60PCDT602026-05-05
10840330706565ProCurePCIT01PCIT012026-05-05
10840330706596ProCurePC631PC6312026-05-05
10840330706671ProCurePC601PC6012026-05-05
10840330705858ProCurePCHC10044PCHC100442026-05-04
10840330706688ProCurePCHSWG15PCHSWG152026-05-04
10840330701560ProCurePCHTF45PCHTF452026-04-28
10840330701577ProCurePCHTF611PCHTF6112026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536910003BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910010BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910027BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910034BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910041BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910058BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910065BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910072BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910089BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910096BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910102BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910119BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536910126BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911109BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911116BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911123BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911130BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911147BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911154BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
00199536911161BluelineTransparent Supply Solutions Ltd.EYQ2026-05-15
10840330704813ProCureTwin Med, LLCEYQ2026-04-28
10840330704837ProCureTwin Med, LLCEYQ2026-04-28
96979303250023CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
96979303250030CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
96979303250054CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
96979303250061CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-12
00199536911048BluelineTransparent Supply Solutions Ltd.EYQ2025-09-22
00199536911055BluelineTransparent Supply Solutions Ltd.EYQ2025-09-22
00199536911062BluelineTransparent Supply Solutions Ltd.EYQ2025-09-22
00199536911079BluelineTransparent Supply Solutions Ltd.EYQ2025-09-22