DEVICE: INTERA (00850014110093)

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Device Record History
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Device Identifier (DI) Information
INTERA
IP-37957
In Commercial Distribution
IP37957
Intera Oncology Inc.
00850014110093
GS1

1
117070072 *Terms of Use
Intera 3000 Hepatic Artery Infusion Pump Tapered Silicone Rubber Catheter (Radiopaque) with Connector. Contents: (1) Catheter: O.D. 2.3mm tapered to O.D. 1.5mm x I.D. 0.6mm x 51.7cm long with (1) Universal Barbed Connector
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
63949 Implantable vascular infusion pump catheter
An implantable, flexible tube intended to be connected to an implantable vascular infusion pump in situ and inserted into a blood vessel to deliver pharmaceuticals from the pump to the cardiovascular system. It typically includes connectors and catheter retention components.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LKK Pump, Infusion, Implanted, Programmable
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Do not use if opened or damaged.
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 2.3 Millimeter
Outer Diameter: 1.5 Millimeter
Catheter Inner Diameter: 0.6 Millimeter
Length: 51.7 Centimeter
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Device Record Status
a67ad77d-2928-4fff-9f2f-d4696e672903
June 10, 2025
4
July 13, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10850014110090 1 00850014110093 In Commercial Distribution Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-909-4815
orders@interaoncology.com
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