Duns Number:809784593
Device Description: Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Tr Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans,W/1 Sided Comfort Panel W/Tape Collar, 1 1/4" (32 Mm.
Catalog Number
-
Brand Name
ACTIVE LIFE
Version/Model Number
175781
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
573bc0e3-7822-4747-b8d5-26d036a59d5a
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
10768455102553
Quantity per Package
14
Contains DI Package
00768455102556
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |