Duns Number:120818216
Device Description: 7" HIGH PRESSURE STNDBR EXT SET WITH BIONECTOR, ROTATING MALE LUER LOCK AND PINCH CLAMP
Catalog Number
CMS-809-1
Brand Name
VYGON
Version/Model Number
CMS-809-1
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
a033cbbd-0a94-4284-82f3-074767b06510
Public Version Date
April 29, 2020
Public Version Number
1
DI Record Publish Date
April 21, 2020
Package DI Number
38498840009896
Quantity per Package
50
Contains DI Package
08498840009895
Package Discontinue Date
April 28, 2020
Package Status
Not 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 |