ivybiomedical.comRT Carbon ECG Leads
Ivy Biomedical Systems, Inc.
IVY BIOMEDICAL SYSTEMS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1221108 | 1221108 | IVY BIOMEDICAL SYSTEMS, INC. | 1 | N | 2026-01-01 | 11 BUSINESS PARK DR. Branford CT US 06405 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816396022553 | ECG Patient Cable - ECG Trunk Cable MRI, 4 Lead, Single pin, 40 in | 203-481-4183 | sales@ivybiomedical.com |
| 00816396022560 | ECG Patient Cable - ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 40 in | 203-481-4183 | sales@ivybiomedical.com |
| 00816396022577 | ECG Patient Cable - ECG Trunk Cable MRI, 4 Lead, Single pin, 40 in, AHA/IEC | 203-481-4183 | sales@ivybiomedical.com |
| 00816396022676 | WGS-100 Respiration Pillow - The Ivy MR Wireless Gating System’s intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not intended for use in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners. | 2036439922 | sales@ivybiomedical.com |
| 00816396022706 | ECG Patient Cable - ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 5 ft | 203-481-4183 | sales@ivybiomedical.com |
| 00816396023550 | WGS-100 Wireless Gating System - The Ivy MR Wireless Gating System’s intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not intended for use in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners. | 2036439922 | sales@ivybiomedical.com |
| 00816396023567 | WGS-100 Transmitter - The Ivy MR Wireless Gating System’s intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not intended for use in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners. | 2036439922 | sales@ivybiomedical.com |
| 00816396023574 | WGS-100 Base Station - The Ivy MR Wireless Gating System’s intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not intended for use in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners. | 2036439922 | sales@ivybiomedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 73149 | 1027151169 | K964961 | MODEL 405T WITH ETCO2 OPTION | CCK | 1997-05-14 |
| 73149 | 1137706385 | K240087 | RT Carbon ECG Leads | DSA | 2024-09-13 |
| 73149 | 1252192568 | K203653 | MRI PPG Patient Cable | LNH | 2021-03-02 |
| 73149 | 1651417458 | K202138 | Cardiac Trigger Monitor | DRT | 2021-05-14 |
| 73149 | 1382726327 | K192852 | MRI ECG Patient Cable | LNH | 2020-03-28 |
| 73149 | 1155091121 | K171778 | MR Wireless Gating System, Model WGS-100 | LNH | 2018-03-14 |
| 73149 | 1509217437 | K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | DRT | 2016-05-27 |
| 73149 | 1113343478 | K110987 | CARDIAC TRIGGER MONITOR | DRT | 2011-07-22 |
| 73149 | 1702822651 | K091985 | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE | DRT | 2009-07-24 |
| 73149 | 1515787746 | K091787 | MODEL 6000 TWO PARAMETER BEDSIDE MONITOR | DQA | 2009-10-09 |
| 73149 | 1436967086 | K083854 | CARDIAC TRIGGER, MODEL: CTM300 | DRT | 2009-02-13 |
| 73149 | 1033756236 | K023616 | PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) | DRT | 2002-11-04 |
| 73149 | 1635859020 | ||||
| 73149 | 1697074518 |
Product Codes Associated With Registrations#
PMN#
Cardiac Trigger Monitor
Ivy Biomedical Systems, Inc.
MRI PPG Patient Cable
Ivy Biomedical Systems, Inc.
MRI ECG Patient Cable
Ivy Biomedical Systems, Inc.
Cardiac Trigger Monitor
Ivy Biomedical Systems, Inc.
CARDIAC TRIGGER MONITOR
IVY BIOMEDICAL SYSTEMS, INC.
MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
IVY BIOMEDICAL SYSTEMS, INC.
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
IVY BIOMEDICAL SYSTEMS, INC.
CARDIAC TRIGGER, MODEL: CTM300
IVY BIOMEDICAL SYSTEMS, INC.
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
IVY BIOMEDICAL SYSTEMS, INC.
MODEL 2000 PULSE OXIMETER
IVY BIOMEDICAL SYSTEMS, INC.
MODEL 405T WITH ETCO2 OPTION
IVY BIOMEDICAL SYSTEMS, INC.
PATIENT MONITOR MODEL 405P
IVY BIOMEDICAL SYSTEMS, INC.
PARAMETERS MONITORES
IVY BIOMEDICAL SYSTEMS, INC.
MODEL 704
IVY BIOMEDICAL SYSTEMS, INC.
MODEL 405
IVY BIOMEDICAL SYSTEMS, INC.
MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.
IVY BIOMEDICAL SYSTEMS, INC.
MODEL 702 ECG/RESPIRATION/TEMPERATURE
IVY BIOMEDICAL SYSTEMS, INC.
PATIENT MONITOR MODEL 701
IVY BIOMEDICAL SYSTEMS, INC.
PATIENT MONITOR MODEL 703
IVY BIOMEDICAL SYSTEMS, INC.
MODEL 700 PATIENT MONITOR
IVY BIOMEDICAL SYSTEMS, INC.
MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR
IVY BIOMEDICAL SYSTEMS, INC.
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
IVY BIOMEDICAL SYSTEMS, INC.
PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403
IVY BIOMEDICAL SYSTEMS, INC.
PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A
IVY BIOMEDICAL SYSTEMS, INC.
GUDID#
WGS-100 Respiration Pillow - The Ivy MR Wireless Gating System’s intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not intended for use in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.
2026-08-03
WGS-100 Wireless Gating System - The Ivy MR Wireless Gating System’s intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not intended for use in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.
2026-08-03
WGS-100 Transmitter - The Ivy MR Wireless Gating System’s intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not intended for use in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.
2026-08-03
WGS-100 Base Station - The Ivy MR Wireless Gating System’s intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition and synchronization of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not intended for use in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.
2026-08-03
ECG Patient Cable - ECG Trunk Cable MRI, 4 Lead, Single pin, 40 in
2023-06-08
ECG Patient Cable - ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 40 in
2023-06-08
ECG Patient Cable - ECG Trunk Cable MRI, 4 Lead, Single pin, 40 in, AHA/IEC
2023-06-08
ECG Patient Cable - ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 5 ft
2023-06-08
ECG Patient Cable - ECG Trunk Cable Shielded, 4 Lead, AHA/IEC, 10 ft
2023-06-08
ECG Trunk Cable - ECG Trunk Cable, Shielded, 3 Lead, AHA/IEC/ 10 ft
2023-06-08
ECG Patient Cable - ECG Trunk Cable, Shielded, 3 Lead, AHA/IEC, 40 in
2023-06-08
ECG Lead Wires - ECG Lead Wires, Shielded, 3 Lead AHA/IEC, 5ft
2023-06-08
ECG Lead Wires - ECG Lead Wires, Metallic, 3 Lead Set, IEC, 36 in
2023-06-08
ECG Lead Wires - ECG Lead Wires, Metallic, 3 Lead Set,AHA, 36 in
2023-06-08
ECG Trunk Cable - ECG Trunk Cable, 4 Lead, AHA, 50ft
2023-06-08
ECG Patient Cable - ECG Patient Cable, Shielded, 3-Lead, AHA, 10 ft
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 3 Lead Set, AHA, 24 in
2016-09-01
ECG Patient Cable - ECG Patient Cable, Shielded, 3-Lead, IEC, 10 ft
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 3 Lead Set, IEC, 24 in
2016-09-01
ECG Patient Cable - ECG Patient Cable, Shielded, 3-Lead, IEC, 40 in
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 3 Lead Set, IEC, 40 in
2016-09-01
ECG Patient Cable - ECG Patient Cable, Shielded, 3-Lead, AHA, 40 in
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 3 Lead Set, AHA, 40 in
2016-09-01
ECG Snap Lead Wires - ECG Snap Lead Wires, Metallic, 3 Lead Set, AHA, 24 in
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 3 Lead Set, AHA, 30 in
2016-09-01
ECG Patient Cable - ECG Patient Cable, Shielded, 4-Lead, AHA, 10 ft
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 4 Lead Set, AHA, 24 in
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 4 Lead Set, AHA, 30 in
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 4 Lead Set, AHA, 36 in
2016-09-01
ECG Patient Cable - ECG Patient Cable, Shielded, 4-Lead, IEC, 10 ft
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 4 Lead Set, IEC, 24 in
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 4 Lead Set, IEC, 30 in
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 4 Lead Set, IEC, 36 in
2016-09-01
ECG Lead Wires - ECG Lead Wires, Metallic, 3 Lead Set, IEC, 30 in
2016-09-01
ECG Patient Cable - ECG Patient Cable, Shielded, 3 Lead, AHA-IEC, 1.5M
2017-08-31
Model 7800 - Cardiac Gating Monitor & Accessory Kit
2023-06-09
Model 7600EP - Cardiac Gating Monitor & Accessory Kit
2023-06-08
UPMM-X - Cardiac Gating Module FRU
2023-06-08
Model 7800 - Cardiac Gating Monitor & Accessory Kit
2023-06-08
Model 7800 - Cardiac Gating Monitor & Accessory Kit
2023-06-08