| Primary Device ID | 00812324000259 |
| NIH Device Record Key | 1b87e14b-a4c1-4e14-83b6-8cbb615e6ace |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEMS Win Air |
| Version Model Number | GW-AIR |
| Catalog Number | GW-AIR |
| Company DUNS | 251043907 |
| Company Name | CardioComm Solutions, Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812324000259 [Primary] |
| DSH | Recorder, Magnetic Tape, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-17 |
| Device Publish Date | 2023-11-09 |
| 00812324000204 - GEMS Win Arrhythmia | 2023-11-17 Global ECG Management System (GEMS) for Windows Arrhythmia |
| 00812324000211 - GEMS Win TTM | 2023-11-17 Global ECG Management System for Windows with Arrhythmia and TTM |
| 00812324000242 - GEMS Win AutoAttendant | 2023-11-17 GEMS Win AutoAttendant |
| 00812324000259 - GEMS Win Air | 2023-11-17GEMS Win Air |
| 00812324000259 - GEMS Win Air | 2023-11-17 GEMS Win Air |
| 00812324000228 - GEMS Win TTM & ICD | 2023-11-16 GEMS Win ARR TTM & Full Pacing |
| 00812324000266 - GEMS Win HL7 | 2023-11-16 HL7 plug-in module for GEMS Win |
| 00812324000044 - HeartCheck CardiBeat | 2019-03-12 HeartCheck CardiBeat portable ECG monitor |
| 00812324000020 - HeartCheck BT PEN Handheld ECG | 2018-07-06 Bluetooth PEN Handheld ECG |