| Primary Device ID | 07290020154408 |
| NIH Device Record Key | b0edd945-cff1-4e2d-b3a2-6ae43c20d7fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BB-613 BPM 16-Unit Multipack |
| Version Model Number | 2.1.0 |
| Catalog Number | BB900000200016 |
| Company DUNS | 532193771 |
| Company Name | BIOBEAT TECHNOLOGIES LTD |
| Device Count | 16 |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 07290020154408 [Unit of Use] |
| GS1 | 17290020154405 [Primary] |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-13 |
| Device Publish Date | 2025-03-05 |
| 07290020154422 - BB-613 BPM KIT | 2025-03-18 |
| 07290020154101 - BB-613W Wrist-Monitor | 2025-03-13 |
| 07290020154309 - BB-613 H@H kit | 2025-03-13 |
| 17290020154009 - BB-613P Chest-Monitor 40-Unit Multipack | 2025-03-13 |
| 07290020154408 - BB-613 BPM 16-Unit Multipack | 2025-03-13 |
| 07290020154408 - BB-613 BPM 16-Unit Multipack | 2025-03-13 |