| Primary Device ID | 05999883490044 |
| NIH Device Record Key | 7f9b6d2e-6867-414a-9830-af704ca36e25 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cardiospy ECG Holter System |
| Version Model Number | EC-12H |
| Company DUNS | 520963286 |
| Company Name | LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Length | 67.5 Millimeter |
| Width | 53 Millimeter |
| Width | 18.5 Millimeter |
| Weight | 50 Gram |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05999883490044 [Primary] |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-12-06 |
| 05999883490075 | The USB-02 Dongle is the hardware key for Cardiospy software that makes possible the use of Card |
| 05999883490044 | The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depe |
| 05999883490013 | The battery powered Cardiospy ECG Holter System provides 1, 2, 3 channel recordings, depending o |
| 05999883490006 | The battery powered Cardiospy ECG Holter System provides 1, 2 channel recordings, depending on t |