FDA.reportPublic FDA data

INTERA

Primary DI
00850014110147
Brand
INTERA
Company
Intera Oncology Inc.
Model
AP-03000H
Catalog number
AP03000H
Device description
Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Published
2021-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKKPump, Infusion, Implanted, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKKPump, Infusion, Implanted, ProgrammableUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P890055074

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P890055074MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMIntera Oncology1996-03-11LKK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014110147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014110147008500141101478500141101470850014110147

GMDN Terms#

Term, Definition table
TermDefinition
Implantable intrathecal infusion pump, nonprogrammableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume30Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not drop
Special Storage Condition, Specify00Do not use if opened or damaged
Special Storage Condition, Specify00Protect Package from Water

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-660-2660intera-US@healthlinkeurope.com
800-909-4815interaoncology-us@healthlinkeurope.com
800-909-4815orders@interaoncology.com

Regulatory Flags#

DUNS number
117070072
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014110024INTERAAP-04011AP040112021-06-23
00850014110048INTERAAP-04013-5AP0401352021-10-06
00850014110055INTERAAP-04032-5AP0403252021-06-23
00850014110154INTERAAP-07004AP070042021-07-28
00850014110093INTERAIP-37957IP379572021-07-13
00850014110017INTERAAP-04009AP040092021-10-18
00850014110031INTERAAP-04030AP040302021-10-18
00850014110130INTERAAP-07004AP070042021-10-18
00850014110079INTERAAP-07014USAP07014US2021-08-13
10850014110014INTERAAP-04009AP040092021-10-18
10850014110038INTERAAP-04030AP040302021-10-18
10850014110045INTERAAP-04013-5AP0401352021-10-06
10850014110021INTERAAP-04011AP040112021-06-23
10850014110052INTERAAP-04032-5AP0403252021-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150021277NAMEDTRONIC, INC.LKK2026-05-02
00763000999414SYNCHROMED™ IIIMEDTRONIC, INC.LKK2026-01-15
00763000999421SYNCHROMED™ IIIMEDTRONIC, INC.LKK2026-01-15
00763000004101NAMEDTRONIC, INC.LKK2025-08-25
00763000574598NAMEDTRONIC, INC.LKK2025-02-10
00763000916633NAMEDTRONIC, INC.LKK2024-05-06
00763000916640NAMEDTRONIC, INC.LKK2024-05-06
00763000916657Ascenda®MEDTRONIC, INC.LKK2024-05-06
00763000916664Ascenda®MEDTRONIC, INC.LKK2024-05-03
00763000916671Ascenda®MEDTRONIC, INC.LKK2024-05-03
00763000825539NAMEDTRONIC, INC.LKK2024-03-30
00763000745073NAMEDTRONIC, INC.LKK2023-12-16
00763000597023SYNCHROMED™ IIIMEDTRONIC, INC.LKK2023-12-15
00763000597030SYNCHROMED™ IIIMEDTRONIC, INC.LKK2023-12-15
00763000825515NAMEDTRONIC, INC.LKK2023-12-09
00763000825522NAMEDTRONIC, INC.LKK2023-12-09
00763000852597Ascenda®MEDTRONIC, INC.LKK2023-12-09
00763000852603Ascenda®MEDTRONIC, INC.LKK2023-12-09
00763000852610Ascenda®MEDTRONIC, INC.LKK2023-12-09
00763000852627Ascenda®MEDTRONIC, INC.LKK2023-12-09
00763000852634Ascenda®MEDTRONIC, INC.LKK2023-12-09
00763000875725NAMEDTRONIC, INC.LKK2023-12-09
00763000875695NAMEDTRONIC, INC.LKK2023-11-16
00763000875701NAMEDTRONIC, INC.LKK2023-11-16
00763000875718NAMEDTRONIC, INC.LKK2023-11-16
00763000875862N'VISION™MEDTRONIC, INC.LKK2023-11-16
00763000632786NAMEDTRONIC, INC.LKK2023-11-05
00763000632793NAMEDTRONIC, INC.LKK2023-11-05
00763000631482NAMEDTRONIC, INC.LKK2023-03-10
00763000301354NAMEDTRONIC, INC.LKK2022-10-09