Duns Number:809784593
Device Description: Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Co Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 10" Opaque, 1 1/2" (38Mm.)
Catalog Number
-
Brand Name
ACTIVELIFE
Version/Model Number
125334
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZQ
Product Code Name
Pouch, Colostomy
Public Device Record Key
5f80f907-039a-4a13-a4f0-3794d4eb0051
Public Version Date
October 18, 2022
Public Version Number
3
DI Record Publish Date
April 19, 2019
Package DI Number
10768455101952
Quantity per Package
20
Contains DI Package
00768455101955
Package Discontinue Date
-
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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |