FDA.reportPublic FDA data

INTERA

Primary DI
00850014110093
Brand
INTERA
Company
Intera Oncology Inc.
Model
IP-37957
Catalog number
IP37957
Device 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
Published
2021-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850014110090PackageGS11In Commercial Distribution
00850014110093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001411009010850014110090
00850014110093008500141100938500141100930850014110093

GMDN Terms#

Term, Definition table
TermDefinition
Implantable vascular infusion pump catheterAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter0
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if opened or damaged.

Contacts#

Phone, Email table
PhoneEmail
800-909-4815orders@interaoncology.com

Regulatory Flags#

DUNS number
117070072
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014110017INTERAAP-04009AP040092021-10-18
00850014110024INTERAAP-04011AP040112021-06-23
00850014110031INTERAAP-04030AP040302021-10-18
00850014110048INTERAAP-04013-5AP0401352021-10-06
00850014110055INTERAAP-04032-5AP0403252021-06-23
00850014110130INTERAAP-07004AP070042021-10-18
00850014110079INTERAAP-07014USAP07014US2021-08-13
00850014110147INTERAAP-03000HAP03000H2021-07-28
00850014110154INTERAAP-07004AP070042021-07-28
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