Duns Number:120818216
Device Description: 6" MICROBORE TRIFURCATED EXT. SET WITH TWO BIONECTOR & 0.2 MICRON FILTER
Catalog Number
AMS-375-1
Brand Name
VYGON
Version/Model Number
AMS-375-1
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
K021395,K021395
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
4127be75-5aaf-4e55-87d5-bf134601373c
Public Version Date
November 08, 2019
Public Version Number
1
DI Record Publish Date
October 31, 2019
Package DI Number
30849884002561
Quantity per Package
100
Contains DI Package
00849884002560
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 |