| Primary Device ID | 00817980020009 |
| NIH Device Record Key | e5a8f276-dd11-437d-88c1-b8e1e8e66758 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vasomedical-Biox™ 1305 3 Channel ECG Holter Recorder |
| Version Model Number | Model 1305 |
| Catalog Number | A10-0083 |
| Company DUNS | 197210248 |
| Company Name | VASOMEDICAL, INC. |
| 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 | false |
| 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 |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com | |
| Phone | +1(516)508-5818 |
| eohara@vasomedical.com |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817980020009 [Primary] |
| DSH | RECORDER, MAGNETIC TAPE, MEDICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-11-29 |