Duns Number:022760922
Device Description: Microbore Extension Set 60”, 0.3 priming volume – dark tubing for light sensitive medicat Microbore Extension Set 60”, 0.3 priming volume – dark tubing for light sensitive medications
Catalog Number
-
Brand Name
IS6003DT
Version/Model Number
IS6003DT
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K003854,K003854
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
12058bd0-1f5b-4e6a-bd71-a98eaeb3d657
Public Version Date
September 19, 2022
Public Version Number
1
DI Record Publish Date
September 09, 2022
Package DI Number
20816336022258
Quantity per Package
50
Contains DI Package
10816336022251
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |