Home GUDID 35019517042560 BCI
Primary DI 35019517042560
Brand BCI
Company ICU MEDICAL, INC.
Model 3049
Published 2016-10-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQO Catheter, Intravascular, Diagnostic Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 35019517042560 Primary GS1 0 15019517042566 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 35019517042560 35019517042560 15019517042566 15019517042566
GMDN Terms# Term, Definition table Term Definition Peripheral vascular infusion catheter A sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor microcatheter for access into superselective small vessels. This is a single-use device.
Regulatory Flags# DUNS number 118380146 Device count 20 Lot or batch true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00842429108574 BOBBY/SOFIA Kit Microvention, Inc. DQO 2025-04-30 00842429108444 Sofia Microvention, Inc. DQO 2024-10-18 00842429108451 Sofia Microvention, Inc. DQO 2024-10-18 00842429108468 Sofia Microvention, Inc. DQO 2024-10-18 00763000541194 RistTM Micro Therapeutics, Inc. DQO 2022-05-01 00763000541200 RistTM Micro Therapeutics, Inc. DQO 2022-05-01 00763000541217 RistTM Micro Therapeutics, Inc. DQO 2022-05-01 00763000413767 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413774 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413781 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413798 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413804 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413811 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00763000413828 Rist™ Micro Therapeutics, Inc. DQO 2020-10-05 00816777025913 Sofia 5F-125cm STR Microvention, Inc. DQO 2018-08-07 00816777025920 Sofia 5F-115cm STR Microvention, Inc. DQO 2018-08-07 00857688007278 Respiguide Delivery System RESPICARDIA, INC. DQO 2018-04-30 00884450089194 EmboCath® Plus BIOSPHERE MEDICAL DQO 2017-05-11 00884450089200 EmboCath® Plus BIOSPHERE MEDICAL DQO 2017-05-11 00866749000202 Morph Universal Deflectable Guide Catheter BIOCARDIA, INC. DQO 2016-10-10 08714729200567 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200574 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200581 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200598 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200604 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200611 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200628 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200635 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200659 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24 08714729200666 Wiseguide ™ BOSTON SCIENTIFIC CORPORATION DQO 2016-09-24