Duns Number:117070072
Device Description: Intera 3000 Hepatic Artery Infusion Pump OR Prep Kit, Contents: (1) Huber Needle 22 Gauge, Intera 3000 Hepatic Artery Infusion Pump OR Prep Kit, Contents: (1) Huber Needle 22 Gauge, (1) Special Bolus Needle, (1) Empty Syringe Barrel with Lid
Catalog Number
AP07004
Brand Name
INTERA
Version/Model Number
AP-07004
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
-
Product Code
PTI
Product Code Name
Non-Coring (Huber) Needle
Public Device Record Key
3617bf7f-8f0f-44dc-a992-69b415a252e7
Public Version Date
June 06, 2022
Public Version Number
2
DI Record Publish Date
October 18, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| 3 | A medical device with high risk that requires premarket approval | 3 |