Intera

FDA UDI

Class III (US FDA UDI)

by Intera Oncology

Identity

Trade Name: INTERA FDA UDI
Generic Name: Implantable vascular infusion pump catheter FDA UDI
Device Name: 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 FDA UDI
Model / Reference: IP-37957 FDA UDI
Description: 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 FDA UDI

Identifiers

Catalog Number: IP37957 FDA UDI
Primary DI / UDI-DI: 00850014110093 FDA UDI
FDA Product Code: LKK FDA UDI
GMDN Term: Implantable vascular infusion pump catheter FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2.3 Millimeter FDA UDI
Outer Diameter — 1.5 Millimeter FDA UDI
Catheter Inner Diameter — 0.6 Millimeter FDA UDI
Length — 51.7 Centimeter FDA UDI

Category: Implantable vascular infusion pump catheter

Intera by Intera Oncology — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Intera Oncology

Sources (1)

FDA UDI a67ad77d-2928-4fff-9f2f-d4696e672903 37 fields · synced Jun 1, 2026