Duns Number:120818216
Device Description: 105" ADMIN SET W 20 DROPS/ML SPIKE DRIP CHAMBER, 0.22 MICRON FILTER, CHECK VALVE & 2 Y-SIT 105" ADMIN SET W 20 DROPS/ML SPIKE DRIP CHAMBER, 0.22 MICRON FILTER, CHECK VALVE & 2 Y-SITES
Catalog Number
AMS-609-1
Brand Name
VYGON
Version/Model Number
AMS-609-1
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
K884370,K884370
Product Code
FPK
Product Code Name
Tubing, fluid delivery
Public Device Record Key
791a7fe1-46fa-4ba8-a466-134969639bc6
Public Version Date
November 22, 2019
Public Version Number
1
DI Record Publish Date
November 14, 2019
Package DI Number
30849884000451
Quantity per Package
50
Contains DI Package
00849884000450
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 |