Duns Number:078740398
Device Description: Abena Slip Flexi Fit Premium holds 128 fluid ounces/3800 ml, for individuals with hip and Abena Slip Flexi Fit Premium holds 128 fluid ounces/3800 ml, for individuals with hip and waist measurements of 43-67".
Catalog Number
-
Brand Name
Abena
Version/Model Number
1000021167
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
4d98de98-9621-413b-bc9a-c932822f8ab2
Public Version Date
August 11, 2022
Public Version Number
1
DI Record Publish Date
August 03, 2022
Package DI Number
57135710001592
Quantity per Package
4
Contains DI Package
05713571001585
Package Discontinue Date
January 01, 2023
Package Status
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 |