Duns Number:120818216
Device Description: 10" WINGED INFUSION SET WITH 20 GA. X 1.5" HUBER NEEDLE
Catalog Number
MBS-2015
Brand Name
VYGON
Version/Model Number
MBS-2015
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
K873957,K873957,K873957
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
ba875cce-8d8d-4dc9-8b30-f999be975372
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
August 16, 2016
Package DI Number
58498840006837
Quantity per Package
21
Contains DI Package
38498840006833
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 | 124 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 833 |