Duns Number:809784593
Device Description: ActiveLife One-Piece Pre-Cut Drainable Pouch with Stomahesive Skin Barrier, with One Sided ActiveLife One-Piece Pre-Cut Drainable Pouch with Stomahesive Skin Barrier, with One Sided Comfort Panel with Tape, 10 in, Opaque, 1 1/2 in (38 mm)
Catalog Number
-
Brand Name
ACTIVELIFE
Version/Model Number
022753
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)
Yes
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
b4aad2c2-5aa2-4764-a5c8-19acf5cfe6fb
Public Version Date
October 28, 2022
Public Version Number
4
DI Record Publish Date
November 09, 2018
Package DI Number
10768455101433
Quantity per Package
14
Contains DI Package
00768455101436
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 |