FDA.reportPublic FDA data

Abena

Primary DI
05703538357176
Brand
Abena
Company
Abena North America, Inc
Model
1556
Device description
"Abri-Fix Soft Cotton Brief without legs Adult Incontinence for individuals with waist and hip measurements from 24 to 30"". Generally is classified as a X-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
05703538357169PackageGS120In Commercial Distribution
05703538357176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05703538357169057035383571695703538357169
05703538357176057035383571765703538357176

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 water.

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
Expiration 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
00190509001032Abena19572020-04-02
00190509001049Abena19582020-04-02
00190509001056Abena19592020-04-02
00190509001315Abena19602020-05-29
00190509001322Abena19612020-05-29
00190509001339Abena19622020-05-29
00190509001346Abena19642020-05-29
00190509001353Abena19652020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05703538498749AbenaAbena North America, IncEYQ2026-02-18
05703538498800AbenaAbena North America, IncEYQ2026-02-18
05703538498862AbenaAbena North America, IncEYQ2026-02-18
05703538498886AbenaAbena North America, IncEYQ2026-02-18
96979303250009CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-13
96979303250016CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-13
96979303250047CuteleafZhangzhou Win Share Co.,Ltd.EYQ2026-01-13
05703538474811AbenaAbena North America, IncEYQ2025-11-17
05703538474835AbenaAbena North America, IncEYQ2025-11-17
05703538474859AbenaAbena North America, IncEYQ2025-11-17
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