FDA.report

Abena

Primary DI
05703538129698
Brand
Abena
Company
ABENA NORTH AMERICA, INC.
Model
4242
Device description
Abri-Fix Pants Adult Incontinence for individuals with waist and hip measurements from 45 to 65". Generally is classified as a XX-Large size.
Published
2020-03-05
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

Related Records

Contact Domains

Product Codes

CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications

CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05703538129711PackageGS160In Commercial Distribution
05703538129698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05703538129711057035381297115703538129711
05703538129698057035381296985703538129698

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight and water.

Sterilization Methods

Method

Contacts

PhoneEmail
844-223-6248info-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

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05713571000014Abena10000212792022-08-08
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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

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