Duns Number:005527098
Device Description: One-Piece Closed Cut-to-Fit Pouch, no tape with Filter, SoftFlex skin barrier, Transparent One-Piece Closed Cut-to-Fit Pouch, no tape with Filter, SoftFlex skin barrier, Transparent, up to 55mm, 2-1/8"
Catalog Number
-
Brand Name
Premier
Version/Model Number
82400
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"
Yes
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
EXB
Product Code Name
COLLECTOR, OSTOMY
Public Device Record Key
c115d884-c4e4-4def-ab21-1863c52251ef
Public Version Date
January 01, 2019
Public Version Number
1
DI Record Publish Date
December 01, 2018
Package DI Number
30610075106647
Quantity per Package
12
Contains DI Package
00610075106646
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |