FDA.reportPublic FDA data

Abena

Primary DI
05703538446153
Brand
Abena
Company
ABENA NORTH AMERICA, INC.
Model
1000020864
Device description
Abena Slip Flexi Fit Premium holds 98 fl oz and is meant for individuals with hip/waist measurements of 43-67".
Published
2022-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
05703538446153PackageGS14In Commercial Distribution
05703538446146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05703538446153057035384461535703538446153
05703538446146057035384461465703538446146

GMDN Terms#

Term, Definition table
TermDefinition
Adult nappyA disposable undergarment (a nappy or diaper) composed of absorbent material and worn between the legs used to collect urine and faeces from an incontinent adult patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18442236248INFO-NA@ABENA.COM

Regulatory Flags#

DUNS number
078740398
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713571000731Abena10000213152022-08-09
05703538457869Abena19999053542022-08-08
05703538458460Abena19999053752022-08-08
05703538458613Abena19999053762022-08-08
05703538458675Abena19999053782022-08-08
05713571000014Abena10000212792022-08-08
05713571000038Abena10000212802022-08-08
05713571000052Abena10000212812022-08-08
05713571000076Abena10000212822022-08-08
05713571000090Abena10000212832022-08-08
05713571000113Abena10000212842022-08-08
05713571000137Abena10000212852022-08-08
05713571000151Abena10000212862022-08-08
05713571000175Abena10000212872022-08-08
05713571000199Abena10000212882022-08-08
05713571000212Abena10000212892022-08-08
05713571000236Abena10000212902022-08-08
05713571000250Abena10000212912022-08-08
05713571000274Abena10000212922022-08-08
05713571000298Abena10000212932022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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