Duns Number:078740398
Device Description: Abena San Premium holds 85 fluid ounces/2500 ml, for individuals for width and length meas Abena San Premium holds 85 fluid ounces/2500 ml, for individuals for width and length measurements of 25x14".
Catalog Number
-
Brand Name
Abena
Version/Model Number
1000021310
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
7f75cf70-35fc-45cd-85f2-bcc8371b0af2
Public Version Date
August 16, 2022
Public Version Number
1
DI Record Publish Date
August 08, 2022
Package DI Number
05713571000632
Quantity per Package
4
Contains DI Package
05713571000625
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 |