Duns Number:120818216
Device Description: 7" MICROBORE EXT. SET WITH MALE/FEMALE LUER LOCKS & SLIDE CLAMP
Catalog Number
AMS-761
Brand Name
VYGON
Version/Model Number
AMS-761
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
K882503,K882503
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
979152b2-71f8-4853-96e5-caf674d96637
Public Version Date
October 19, 2022
Public Version Number
1
DI Record Publish Date
October 11, 2022
Package DI Number
30849884005951
Quantity per Package
50
Contains DI Package
00849884005950
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 |