Duns Number:041810693
Catalog Number
-
Brand Name
Precision Delivery IV Extension Set, Amber
Version/Model Number
PDV60A
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K202672,K202672
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
2d9e9c30-a34b-4ce5-b1a6-75daadc82a41
Public Version Date
July 02, 2021
Public Version Number
1
DI Record Publish Date
June 24, 2021
Package DI Number
20634624921065
Quantity per Package
50
Contains DI Package
00634624921061
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 | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 168 |
U | Unclassified | 8 |