Duns Number:791238046
Device Description: Silicone Enteral Feeding Tube - TwistLok - 40cm by 6.5 French
Catalog Number
-
Brand Name
Medela
Version/Model Number
ENSI4065
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"
Yes
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
K090559,K090559,K090559
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
ba3f692f-bb0f-498c-b436-a5d0b73d4cab
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 16, 2017
Package DI Number
10859950007372
Quantity per Package
10
Contains DI Package
00859950007375
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 133 |