EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
GENERAL DEVICES
GENERAL DEVICES LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2244646 | 2244646 | GENERAL DEVICES LLC | 1 | N | 2020-04-25 | 1000 River St Ridgefield NJ US 07657 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 36437 | 1303383623 | K993202 | EIM-107 PREP-CHECK | GZO | 1999-12-17 |
| 36437 | 1721683650 | K830876 | PREP-CHECK | KRC | 1983-05-18 |
| 36437 | 1279451286 | K013533 | EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) | DRG | 2002-01-18 |
| 36437 | 1227734166 |
Product Codes Associated With Registrations#
PMN#
ROSETTA-LT/ROSETTA-RX
GENERAL DEVICES
EIM-107 PREP-CHECK
GENERAL DEVICES
GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300
GENERAL DEVICES
GEMSCOM SERIES 5000,
GENERAL DEVICES
GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)
GENERAL DEVICES
GEMSCOM SERIES 3000
GENERAL DEVICES
TRU-VIEW MULTI-CHANNEL DISPLAY
GENERAL DEVICES
MODIFIED DR-2C/PMC 100
GENERAL DEVICES
DR-2C (MODIFICATION)
GENERAL DEVICES
DR-2C
GENERAL DEVICES
AP-CHECK
GENERAL DEVICES
PREP-CHECK
GENERAL DEVICES
GUDID#
GD - The CAREpoint Workstation (Version 1 and 2) communication console is a standard radio/telephony communications console used for vice and data communications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e. 2 way radio, landline, wireless telephone) as which are commonly used for commercial and public safety (i.e. police, fire, EMS) communication purposes.
2016-09-23
GD - "The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 25 Lead EEG with 25 Pin Female ""D"" Connector (All 25 Pins Wired) . "
2020-04-02
GD - The Prep-Check 10Hz is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes a applied to patients. This version measures impedance at 10 Hz frequency.
2016-09-23
GD - The Prep-Check 30Hz is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes a applied to patients. Impedance readings are measured at 30 Hz.
2016-09-23
GD - The Prep-Check Plus, 20 pin model is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 20 Safety DIN Connectors and is used while patients are sleeping.
2016-09-23
GD - "The Prep-Check Plus, 37 pin, is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 37 Lead EEG with 37 Pin Female ""D"" Connector (All 37 Pins Wired) . "
2016-09-23
GD - "The Prep-Check Plus, 50 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 50 Lead EEG with 50 Pin Female ""D"" Connector (All 50 Pins Wired) . "
2016-09-23
GD - The Prep-Check Plus, 68 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 50 Lead EEG with 68 Pin Female sub-miniature Dual Inline Connector (50 Lead Wired) .
2016-09-23
GD - The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators over radio/phone communications systems.
2016-09-23
GD - "The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 25 Lead EEG with 25 Pin Female ""D"" Connector (All 25 Pins Wired) . "
2016-09-23