Duns Number:120818216
Device Description: 84" ADMINISTRATION SET WITH UNIVERSAL SPIKE .22 MICRON FILTER, INJECTION SITE & MALE LL
Catalog Number
AMS-975-1
Brand Name
VYGON
Version/Model Number
AMS-975-1
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
K011336,K011336
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
17903caa-87bf-493c-90a2-2e41f622d8e1
Public Version Date
December 20, 2019
Public Version Number
1
DI Record Publish Date
December 12, 2019
Package DI Number
30849884000277
Quantity per Package
50
Contains DI Package
00849884000276
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 |