Duns Number:783518983
Device Description: X- Large Adult Diapers48 Diapers per box4 vacuum sealed bags of 12 diapersAnti-Leak GuardD X- Large Adult Diapers48 Diapers per box4 vacuum sealed bags of 12 diapersAnti-Leak GuardDouble adjustable stripsWetness indicator
Catalog Number
-
Brand Name
Comfort Shield Adult Diapers X-LARGE
Version/Model Number
CSDXL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
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
9991248b-506c-4d3c-83f9-5d0ac6d3ba4a
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
February 27, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |