FDA.reportPublic FDA data

FLUFSAN

Primary DI
08015013406000
Brand
FLUFSAN
Company
EUROPROSAN SPA
Model
Flufsan 40X60
Catalog number
406000
Device description
Waterproof bed mattress cover 40X60 cm , single-use15 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
08015013406000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08015013406000080150134060008015013406000

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpad, non-antimicrobial, single-useA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.

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
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
08015013501439FLUFSANADULT PANTS LARGE EXTRA DAY5014392025-01-31

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Primary DI, Brand, Company table
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