| Primary Device ID | B0024010U3 |
| NIH Device Record Key | 32ec46b2-b568-4333-89d1-0a02f4b18729 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rescuer Child BVM Manual Rescusitator |
| Version Model Number | 4010U |
| Catalog Number | 4010U |
| Company DUNS | 200103823 |
| Company Name | B.L.S. Systems Limited |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 905 339 1069 |
| tedreesor@blssystemsltd.com | |
| Phone | 905 339 1069 |
| tedreesor@blssystemsltd.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B0024010U0 [Primary] |
| HIBCC | B0024010U3 [Package] Contains: B0024010U0 Package: Case of 12 [12 Units] In Commercial Distribution |
| BTM | Ventilator, Emergency, Manual (Resuscitator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-13 |
| B0024050RB7 - Rescuer | 2024-06-20 Replacement reservoir bag (2.9L) for 4000 series manual resuscitator |
| B0023000X7 - Rescuer | 2023-12-19 Rescuer CPR Shield with gloves |
| B0026200U0 - Rescuer O-Mask | 2021-04-09 Rescuer O-Mask with Universal Tubing (Large Adult) |
| B0026205U7 - Rescuer O-Mask with Universal Oxygen Tubing (Small Adult) | 2021-04-09 Rescuer O-Mask with Universal Oxygen Tubing (Small Adult) |
| B0026210U7 - Rescuer O-Mask Oxygen Mask with Universal Tubing | 2021-04-09 Rescuer O-Mask Oxygen Mask with Universal Tubing (Child) |
| B0024000F0 - Rescuer | 2021-01-18 HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator) |
| 00627843557524 - RUSCH | 2020-01-17 Blue RUSCH branded adult manual resuscitator, oxygen reservoir tubing, swivel connector, medication port, Peep connector and med |
| 00627843557531 - RUSCH | 2020-01-17 Blue RUSCH branded Adult sized manual resuscitator , oxygen reservoir bag, swivel connector, medication port, PEEP connector and |