| Primary Device ID | B0028710M6 |
| NIH Device Record Key | 8bd0458a-004a-432c-938a-390840449017 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rescuer CPAP Small Deluxe CPAP Mask only |
| Version Model Number | 8710M |
| Catalog Number | 8710M |
| 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 | B0028710M6 [Package] Contains: B0028810M0 Package: Carton [30 Units] In Commercial Distribution |
| HIBCC | B0028810M0 [Primary] |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-02 |
| Device Publish Date | 2018-10-02 |
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| 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) |
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