DEVICE: INTERA (00850014110147)

Device Identifier (DI) Information

INTERA
AP-03000H
In Commercial Distribution
AP03000H
INTERA ONCOLOGY INC.
00850014110147
GS1

1
117070072 *Terms of Use
Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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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 [?]
P890055 074
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Protect Package from Water
Special Storage Condition, Specify: Do not drop
Special Storage Condition, Specify: Do not use if opened or damaged
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 30 Milliliter
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Device Record Status

571c7621-35c9-42d4-ac45-92a7abd9fc51
August 05, 2021
1
July 28, 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
No Package DIs found
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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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
800-660-2660
intera-US@healthlinkeurope.com
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