Duns Number:791238046
Device Description: Polyurethane Enteral Feeding Tube - TwistLok - 20in by 8 French
Catalog Number
-
Brand Name
Medela
Version/Model Number
ENPU2080
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
K102548,K102548,K102548
Product Code
KNT
Product Code Name
Tubes, Gastrointestinal (And Accessories)
Public Device Record Key
f3ceb279-cdc2-46a0-8849-b0a3d9ef58e8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 16, 2017
Package DI Number
10859950007310
Quantity per Package
10
Contains DI Package
00859950007313
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 |