FDA.reportPublic FDA data

FLUFSAN

Primary DI
08015013502474
Brand
FLUFSAN
Company
EUROPROSAN SPA
Model
ADULT PANTS LARGE MAXI SUPERNIGHT
Catalog number
502474
Device description
ADULT INCONTINENCE PANTS ACTIVE - SIZE LARGE MAXIDEVICE, INCONTINENCE NON-STERILE14 PIECES PER BAG
Published
2025-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
08015013502474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08015013502474080150135024748015013502474

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants, single-useAn underwear designed to retain urine leakage in incontinent adults and older children. It typically consists of a single-use man?s brief or woman?s panty with external softness and shape resembling regular underwear, and an internal pad and/or isolated shell capable of retaining the urine of patients with light or medium incontinence while keeping the skin dry. The device is used in healthcare facilities or at home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429466097
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08015013301503FLUFSANFLUFSAN SOFT XLARGE DAY3015032025-01-31
08015013301510FLUFSANFLUFSAN SOFT MEDIUM NIGHT 3015102025-01-31
08015013301527FLUFSANFLUFSAN SOFT MEDIUM SUPER NIGHT 3015272025-01-31
08015013301534FLUFSANFLUFSAN SOFT LARGE NIGHT 3015342025-01-31
08015013301541FLUFSANFLUFSAN SOFT LARGE SUPER NIGHT 3015412025-01-31
08015013301558FLUFSANFLUFSAN SOFT XLARGE NIGHT 3015582025-01-31
08015013301565FLUFSANFLUFSAN SOFT SMALL DAY & NIGHT3015652025-01-31
08015013301572FLUFSANFLUFSAN SOFT MEDIUM DAY3015722025-01-31
08015013301589FLUFSANFLUFSAN SOFT XLARGE SUPER NIGHT 3015892025-01-31
08015013301596FLUFSANFLUFSAN SOFT LARGE DAY3015962025-01-31
08015013360906FLUFSANFlufsan 80X180 with wings3609062025-01-31
08015013365956FLUFSANFlufsan 60X904000692025-01-31
08015013400022FLUFSANFlufsan 60X604000222025-01-31
08015013406000FLUFSANFlufsan 40X604060002025-01-31
08015013432030FLUFSANFlufsan 60x90 COMPACT4320302025-01-31
08015013500180FLUFSANSUPER 20x60 cm5001802025-01-31
08015013501019FLUFSANADULT PANTS X-SMALL SUPER NIGHT5010192025-01-31
08015013501064FLUFSANADULT PANTS XXL SUPER NIGHT5010642025-01-31
08015013501415FLUFSANADULT PANTS SMALL EXTRA DAY5014152025-01-31
08015013501422FLUFSANADULT PANTS MEDIO EXTRA DAY5014222025-01-31

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
10840330704820ProCureTwin 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