Home GUDID 50884908115104 C3 Wave System
Primary DI 50884908115104
Brand C3 Wave System
Company Medical Components, Inc.
Model MRC3A001
Device description C3 Wave ECG Electrodes and Prep pads
Published 2015-11-11
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name LJS Catheter,intravascular,therapeutic,long-term greater than 30 days
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50884908115104 Package GS1 25 Not in Commercial Distribution 00884908115109 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 50884908115104 50884908115104 00884908115109 00884908115109 884908115109 0884908115109
GMDN Terms# Term, Definition table Term Definition Central venous catheter navigation system, electrocardiographic An assembly of noninvasive devices intended to use electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC), central venous catheter (CVC), haemodialysis catheter]. It includes a portable battery-powered control unit, ECG cable(s), and ECG lead(s). The catheter (not included) is used as an intravascular electrode, with the guidewire or intraluminal saline used as a conductor. The control unit processes ECG signals and sends them to a separate off-the-shelf device (e.g., smartphone), whereby intravascular ECG changes indicate catheter position typically in conjunction with skin surface ECG data.
Regulatory Flags# DUNS number 038000253 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 true 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 00801741240034 PowerPICC SOLO Bard Access Systems, Inc. LJS 2026-05-27 00801741240041 PowerPICC Provena SOLO Bard Access Systems, Inc. LJS 2026-05-27 00801741240058 PowerPICC Provena SOLO Bard Access Systems, Inc. LJS 2026-05-27 00801741240065 PowerPICC Provena SOLO Catheter with Sherlock 3CG Bard Access Systems, Inc. LJS 2026-05-27 00801741240072 PowerPICC Provena SOLO Catheter with Sherlock 3CG Bard Access Systems, Inc. LJS 2026-05-27 H787MRC3S9110 AngioDynamics ANGIODYNAMICS, INC. LJS 2022-10-25 H787MRC3S9200 AngioDynamics ANGIODYNAMICS, INC. LJS 2022-10-25 H787MRC3S9210 AngioDynamics ANGIODYNAMICS, INC. LJS 2022-10-25 H787MRC3R0001 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3R0031 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S900 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S910 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S9150 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S9160 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S920 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S9220 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S930 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S940 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S950 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S960 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H787MRC3S970 C3 WAVE SYSTEM ANGIODYNAMICS, INC. LJS 2022-04-08 H965458160 BioFlo NAVILYST MEDICAL, INC. LJS 2022-02-01 H965458560 BioFlo NAVILYST MEDICAL, INC. LJS 2022-02-01 H96560M13031150 BioFlo NAVILYST MEDICAL, INC. LJS 2021-06-24 H96560M13031130 BioFlo NAVILYST MEDICAL, INC. LJS 2021-06-17 H96560M13031160 BioFlo NAVILYST MEDICAL, INC. LJS 2021-06-17 H96560M0411550 BioFlo NAVILYST MEDICAL, INC. LJS 2021-05-14 H96560M0411560 BioFlo NAVILYST MEDICAL, INC. LJS 2021-05-14 H96560M13031110 BioFlo NAVILYST MEDICAL, INC. LJS 2021-03-19 H954PKM033511S0 BioFlo NAVILYST MEDICAL, INC. LJS 2021-03-08
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