Duns Number:240992693
Device Description: FEEDING TUBE EXTENSION SET, ENTERAL ONLY, FOR PEDIATRIC USE
Catalog Number
54-7059
Brand Name
MED-RX
Version/Model Number
54-7059
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
K100700,K100700
Product Code
FPD
Product Code Name
Tube, Feeding
Public Device Record Key
5c098355-3120-491d-9e6b-b17908a61d7c
Public Version Date
June 06, 2019
Public Version Number
1
DI Record Publish Date
May 29, 2019
Package DI Number
50628725003868
Quantity per Package
50
Contains DI Package
00628725003863
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |