| Primary Device ID | B00215062 |
| NIH Device Record Key | 4382abe5-e80d-4d6a-850d-89f678d7272a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rescuer Disposable Resuscitation Cushion Mask (#4 |
| Version Model Number | 1506 |
| Catalog Number | 1506 |
| Company DUNS | 200103823 |
| Company Name | B.L.S. Systems Limited |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 9053391069 |
| tedreesor@blssystemsltd.com | |
| Phone | 9053391069 |
| tedreesor@blssystemsltd.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B00215060 [Primary] |
| HIBCC | B00215062 [Package] Contains: B00215060 Package: Bag [10 Units] In Commercial Distribution |
| BSJ | Mask, Gas, Anesthetic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-05 |
| Device Publish Date | 2018-10-03 |
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| 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 |