Duns Number:016898496
Device Description: Nasogastric Sump Tube with PreVent® Anti-Reflux Filter And Lopez Valve®
Catalog Number
0056160
Brand Name
Nasogastric Sump Tube with PreVent® Anti-Reflux Filter And Lopez Valve®
Version/Model Number
0056160
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
FEG
Product Code Name
TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
Public Device Record Key
7558c55e-0331-4878-b594-7642b36580ba
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 16, 2016
Package DI Number
10801741052399
Quantity per Package
50
Contains DI Package
00801741052392
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 472 |
2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
U | Unclassified | 10 |