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 |
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.
MR Wireless Gating System, Model WGS-100
Ivy Biomedical Systems, Inc
Cardiac Trigger Monitor
Ivy Biomedical Systems, Inc.
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization 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#
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
Model 7600 - Cardiac Gating Module
2023-06-08
Model 7600EP - Cardiac Gating Monitor & Accessory Kit
2023-06-08
Model 7600EP - Cardiac Gating Monitor & Accessory Kit
2023-06-08
Model 7600EP - Cardiac Gating Monitor & Accessory Kit
2023-06-08