INTERA

Basic Information

• Brand Name: INTERA
• Primary DI: 00850014110147
• Version / Model: AP-03000H
• Catalog Number: AP03000H
• Company Name: INTERA ONCOLOGY INC.
• Labeler DUNS: 117070072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-28
• Public Version: 2
• Public Version Date: 2021-10-19
• Public Version Status: Update
• Public Device Record Key: 571c7621-35c9-42d4-ac45-92a7abd9fc51

Device Description

Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKK	Pump, Infusion, Implanted, Programmable	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
34071	Implantable intrathecal infusion pump, nonprogrammable	A battery-powered, nonprogrammable, sterile device designed to be implanted in a patient for the storing and subarachnoid administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) may enable delivery of a bolus of medication, typically patient-controlled with mechanical restrictions that limit the refill rate of the device, or it may provide a constant flow of medication at a factory-set rate. The device typically consists of a drug reservoir, usually implanted under the skin of the lower abdomen, and a connected catheter placed into the spinal fluid space.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850014110147	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P890055	074

Device Sizes

Type	Value	Unit	Text
Total Volume	30	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect Package from Water
• Type: Special Storage Condition, Specify
• Special Conditions: Do not drop
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if opened or damaged