Duns Number:080935429
Device Description: Dual Lumen Stomach Tube Multi-functional Port with ENFit Connection. For use with ENFit Co Dual Lumen Stomach Tube Multi-functional Port with ENFit Connection. For use with ENFit Connection System.
Catalog Number
7771210E
Brand Name
Salem Sump
Version/Model Number
7771210E
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
PIF
Product Code Name
Gastrointestinal Tubes with Enteral Specific Connectors
Public Device Record Key
5260be15-30b3-444e-ba36-b9ed726f7961
Public Version Date
November 08, 2021
Public Version Number
6
DI Record Publish Date
March 06, 2018
Package DI Number
20884521582719
Quantity per Package
10
Contains DI Package
10884521582712
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |