Home GUDID 00850014110154 INTERA
Primary DI 00850014110154
Brand INTERA
Company Intera Oncology Inc.
Model AP-07004
Catalog number AP07004
Device description Intera 3000 Hepatic Artery Infusion Pump OR Prep Kit, Contents: (1) Huber Needle 22 Gauge, (1) Special Bolus Needle, (1) Empty Syringe Barrel with Lid
Published 2021-07-28
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LKK Pump, Infusion, Implanted, Programmable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LKK Pump, Infusion, Implanted, Programmable Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850014110154 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850014110154 00850014110154 850014110154 0850014110154
GMDN Terms# Term, Definition table Term Definition Hypodermic needle, single-use A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 0 Special Storage Condition, Specify 0 0 Do not use if opened or damaged Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 117070072 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00199150021277 NA MEDTRONIC, INC. LKK 2026-05-02 00763000999414 SYNCHROMED™ III MEDTRONIC, INC. LKK 2026-01-15 00763000999421 SYNCHROMED™ III MEDTRONIC, INC. LKK 2026-01-15 00763000004101 NA MEDTRONIC, INC. LKK 2025-08-25 00763000574598 NA MEDTRONIC, INC. LKK 2025-02-10 00763000916633 NA MEDTRONIC, INC. LKK 2024-05-06 00763000916640 NA MEDTRONIC, INC. LKK 2024-05-06 00763000916657 Ascenda® MEDTRONIC, INC. LKK 2024-05-06 00763000916664 Ascenda® MEDTRONIC, INC. LKK 2024-05-03 00763000916671 Ascenda® MEDTRONIC, INC. LKK 2024-05-03 00763000825539 NA MEDTRONIC, INC. LKK 2024-03-30 00763000745073 NA MEDTRONIC, INC. LKK 2023-12-16 00763000597023 SYNCHROMED™ III MEDTRONIC, INC. LKK 2023-12-15 00763000597030 SYNCHROMED™ III MEDTRONIC, INC. LKK 2023-12-15 00763000825515 NA MEDTRONIC, INC. LKK 2023-12-09 00763000825522 NA MEDTRONIC, INC. LKK 2023-12-09 00763000852597 Ascenda® MEDTRONIC, INC. LKK 2023-12-09 00763000852603 Ascenda® MEDTRONIC, INC. LKK 2023-12-09 00763000852610 Ascenda® MEDTRONIC, INC. LKK 2023-12-09 00763000852627 Ascenda® MEDTRONIC, INC. LKK 2023-12-09 00763000852634 Ascenda® MEDTRONIC, INC. LKK 2023-12-09 00763000875725 NA MEDTRONIC, INC. LKK 2023-12-09 00763000875695 NA MEDTRONIC, INC. LKK 2023-11-16 00763000875701 NA MEDTRONIC, INC. LKK 2023-11-16 00763000875718 NA MEDTRONIC, INC. LKK 2023-11-16 00763000875862 N'VISION™ MEDTRONIC, INC. LKK 2023-11-16 00763000632786 NA MEDTRONIC, INC. LKK 2023-11-05 00763000632793 NA MEDTRONIC, INC. LKK 2023-11-05 00763000631482 NA MEDTRONIC, INC. LKK 2023-03-10 00763000301354 NA MEDTRONIC, INC. LKK 2022-10-09