Duns Number:183325125
Device Description: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 14FR
Catalog Number
70-0053-114
Brand Name
EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector
Version/Model Number
M00509970
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
K142075,K142075
Product Code
PIF
Product Code Name
Gastrointestinal Tubes With Enteral Specific Connectors
Public Device Record Key
2465f6d5-42b0-4431-b8a4-534b0262109b
Public Version Date
April 20, 2020
Public Version Number
5
DI Record Publish Date
August 03, 2016
Package DI Number
00813939024012
Quantity per Package
5
Contains DI Package
00813939023732
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 121 |