| Primary Device ID | B963BPM201W1 |
| NIH Device Record Key | 1da0a14d-613f-4204-a6ee-c314bf66f7ed |
| Commercial Distribution Discontinuation | 2021-01-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BlackBox RPM |
| Version Model Number | BPM-201W |
| Company DUNS | 117652799 |
| Company Name | Blackbox Remote Patient Monitoring LLC |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B963BPM201W1 [Primary] |
| HIBCC | BB1BB963201W1 [Package] Package: Carton [10 Units] Discontinued: 2021-01-01 In Commercial Distribution |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
[B963BPM201W1]
High-level Disinfectant
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-20 |
| Device Publish Date | 2020-10-12 |
| B963BPM201W1 | Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app. |
| BB4B963PO401W1 | Pulse Oximeter |
| B963102C1 | Cellular Blood Pressure monitor |
| B963103C0 | Cellular blood pressure monitor |