Duns Number:183325125
Device Description: Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 16 FR
Catalog Number
70-0060-116
Brand Name
Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
Version/Model Number
SBRD-16-ENF
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
K130611,K130611
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
e693f54b-3a2e-4785-b6d7-e8960276a8f7
Public Version Date
April 20, 2020
Public Version Number
5
DI Record Publish Date
August 01, 2016
Package DI Number
10827002447827
Quantity per Package
10
Contains DI Package
00827002447820
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 |