Duns Number:078740398
Device Description: Abri-Form Premium Adult incontinence holds 75 fluid ounces/2200 ml, for individuals with w Abri-Form Premium Adult incontinence holds 75 fluid ounces/2200 ml, for individuals with waist and hip measurements from 24" to 34". Generally is classified as a S size
Catalog Number
-
Brand Name
Abena
Version/Model Number
43056
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2023
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EYQ
Product Code Name
Garment, Protective, For Incontinence
Public Device Record Key
6aede27a-a43b-4c20-9bbe-4b3ee4317156
Public Version Date
January 03, 2022
Public Version Number
3
DI Record Publish Date
March 05, 2020
Package DI Number
05703538759871
Quantity per Package
3
Contains DI Package
05703538759857
Package Discontinue Date
January 01, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 127 |