Duns Number:117070072
Device Description: Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Catalog Number
AP03000H
Brand Name
INTERA
Version/Model Number
AP-03000H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
P890055
Product Code
LKK
Product Code Name
Pump, Infusion, Implanted, Programmable
Public Device Record Key
571c7621-35c9-42d4-ac45-92a7abd9fc51
Public Version Date
October 19, 2021
Public Version Number
2
DI Record Publish Date
July 28, 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 |