Duns Number:600363369
Device Description: The Fidmi Medical Low Profile Gastrostomy Device is a single use, sterile, disposable devi The Fidmi Medical Low Profile Gastrostomy Device is a single use, sterile, disposable device, that allows for enteral nutriton and / or medicaton delivery directly into the stomach. The PEG placement kit is supplied with the components needed for device placement.
Catalog Number
FG-20F-YELLOW
Brand Name
Low Profile Enteral Feeding Device Kit
Version/Model Number
FG-20F-YELLOW
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
KGC
Product Code Name
Tube, Gastro-Enterostomy
Public Device Record Key
933b0e6c-82bd-41ba-b7a3-cfc0513b0d4b
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 |