Duns Number:809784593
Device Description: Flexi-Seal PROTECT PLUS Fecal Management System with Luer connector
Catalog Number
-
Brand Name
FLEXI-SEAL
Version/Model Number
422303
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
678c9a6d-0dc2-493f-a552-aa95a4b5b47f
Public Version Date
October 11, 2022
Public Version Number
2
DI Record Publish Date
November 18, 2019
Package DI Number
10768455157157
Quantity per Package
3
Contains DI Package
00768455157150
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| 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 |