Duns Number:008124539
Catalog Number
-
Brand Name
Gastrostomy Tube, 3 Port, 22fr, NON-ENFit
Version/Model Number
5123
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
FPD
Product Code Name
Tube, Feeding
Public Device Record Key
0a01445f-8a59-465a-84d0-2ac7c74b570b
Public Version Date
December 25, 2020
Public Version Number
3
DI Record Publish Date
October 01, 2019
Package DI Number
00616784512334
Quantity per Package
5
Contains DI Package
00616784512310
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 694 |
2 | A medical device with a moderate to high risk that requires special controls. | 226 |
3 | A medical device with high risk that requires premarket approval | 2 |