Duns Number:600363369
Device Description: The Replacement Feeding Tube is designed to be replaced when needed. It is attached to the The Replacement Feeding Tube is designed to be replaced when needed. It is attached to the placed PEG device as it is slid into its location within the tube resulting in its distal end to reach the distal end of the main tube and internal bumper thus allowing the required substances (food or medications) to be inserted directly into the stomach.
Catalog Number
FG-20F-PINK-REP
Brand Name
Replaceable Inner Tubes
Version/Model Number
FG-20F-PINK-REP
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
dff26684-f28b-4966-bd59-f35699fc79de
Public Version Date
August 23, 2021
Public Version Number
1
DI Record Publish Date
August 15, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |