Duns Number:120818216
Device Description: 14" STANDARDBORE EXTENSION SET WITH 0.2 MICRON FILTER AND NEEDLELESS Y-SITE
Catalog Number
SS-426
Brand Name
VYGON
Version/Model Number
SS-426
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
FPB
Product Code Name
Filter, infusion line
Public Device Record Key
824916b0-7c2c-4e61-9696-4603f828104b
Public Version Date
December 24, 2019
Public Version Number
1
DI Record Publish Date
December 16, 2019
Package DI Number
30849884000338
Quantity per Package
50
Contains DI Package
00849884000337
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 |