Duns Number:120818216
Device Description: 36" MICROBORE EXTENSION SET WITH MALE/FEMALE LUER LOCKS
Catalog Number
AMS-436
Brand Name
VYGON
Version/Model Number
AMS-436
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
K101368,K101368
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
75b6d1cb-08cd-4113-97b8-4025fae13e51
Public Version Date
June 25, 2019
Public Version Number
1
DI Record Publish Date
June 17, 2019
Package DI Number
38498840012650
Quantity per Package
50
Contains DI Package
08498840012659
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 |