| Primary Device ID | B00287001 |
| NIH Device Record Key | 06f1836e-a9b9-479e-95f2-67fd0219f6c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rescuer Emergency CPAP System |
| Version Model Number | 8700 |
| Catalog Number | 8700 |
| 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 | 9053391069 |
| tedreesor@blssystemsltd.com | |
| Phone | 9053391069 |
| tedreesor@blssystemsltd.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B00287000 [Primary] |
| HIBCC | B00287001 [Package] Contains: B00287000 Package: Case of 6 [6 Units] In Commercial Distribution |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure |
| 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 | 2015-05-05 |
| B20087101 | Rescuer Emergency CPAP Systems with small CPAP mask and pre-attached bonnet is a single patient |
| B00287551 | Rescuer Emergency CPAP System with #4 Cushion Mask and silicone head strap used for patients exh |
| B20087501 | Rescuer Emergency CPAP System with #6 cushion mask and silicone head strap used to deliver conti |
| B00287050 | Rescuer Emergency CPAP System with Medium sized CPAP mask and pre-attached bonnet used for acute |
| B00287001 | Rescuer Emergency CPAP System is a disposable CPAP generator with CPAP mask and pre-attached bon |