FDA.reportPublic FDA data

Abena

Primary DI
05703538128455
Brand
Abena
Company
Abena North America, Inc
Model
4211
Device description
"Abri-Fix Man Adult incontinence for individuals with waist and hip measurements from 28 to 34"". Generally is classified as a Small size."
Published
2020-03-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
05703538128479PackageGS110In Commercial Distribution
05703538128455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05703538128479057035381284795703538128479
05703538128455057035381284555703538128455

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight and waters.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-223-6248info-na@abena.com

Regulatory Flags#

DUNS number
078740398
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713571010792Abena10000310562026-03-30
05713571010815Abena10000310572026-03-30
05703538498732Abena10000251072026-02-18
05703538498794Abena10000251102026-02-18
05703538498855Abena10000251132026-02-18
05703538498879Abena10000251142026-02-18
05703538498749Abena10000251072026-02-18
05703538498800Abena10000251102026-02-18
05703538498862Abena10000251132026-02-18
05703538498886Abena10000251142026-02-18
05703538382246Abena171622020-03-05
05703538330254Abena92562020-03-05
05703538357176Abena15562020-03-05
00190509001032Abena19572020-04-02
00190509001049Abena19582020-04-02
00190509001056Abena19592020-04-02
00190509001315Abena19602020-05-29
00190509001322Abena19612020-05-29
00190509001339Abena19622020-05-29
00190509001346Abena19642020-05-29

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