FDA.report

FLUFSAN

Primary DI
08015013365956
Brand
FLUFSAN
Company
EUROPROSAN SPA
Model
Flufsan 60X90
Catalog number
400069
Device description
Waterproof bed mattress cover 60X90 cm , single-use 15 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
08015013365956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08015013365956080150133659568015013365956

GMDN Terms

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

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
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
08015013501439FLUFSANADULT PANTS LARGE EXTRA DAY5014392025-01-31

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