Duns Number:926603486
Device Description: are connected to IV catheters to allow a larger distance between the patient and the fluid are connected to IV catheters to allow a larger distance between the patient and the fluid being administered which is often necessary due to the size and volume of equipment being used at any one time
Catalog Number
DU2260
Brand Name
IV Extension Set 6"
Version/Model Number
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"
Yes
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
K151151,K151151
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
a6c645a9-1c53-4132-89ec-8580f3a18bd5
Public Version Date
August 27, 2020
Public Version Number
1
DI Record Publish Date
August 19, 2020
Package DI Number
10850014433137
Quantity per Package
100
Contains DI Package
00850014433130
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |