Duns Number:021717889
Device Description: Low Profile Button Continuous Feeding Set ENFit
Catalog Number
-
Brand Name
EndoVive Button Right Angle Feeding Set
Version/Model Number
M00501060
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
PIF
Product Code Name
Gastrointestinal Tubes with Enteral Specific Connectors
Public Device Record Key
9964af0d-c943-455a-a2ea-57aff4a0d20d
Public Version Date
September 30, 2020
Public Version Number
3
DI Record Publish Date
October 15, 2016
Package DI Number
08714729863281
Quantity per Package
10
Contains DI Package
08714729863274
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |