FDA.report

FLUFSAN

Primary DI
08015013501484
Brand
FLUFSAN
Company
EUROPROSAN SPA
Model
ADULT PANTS EXTRALARGE SUPER NIGHT
Catalog number
501484
Device description
ADULT INCONTINENCE PANTS ACTIVE - SIZE XLARGE SUPER DEVICE, INCONTINENCE NON-STERILE 14 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
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications

CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08015013501484PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
429466097
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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 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

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