| Primary Device ID | B036101325 |
| NIH Device Record Key | e8ed02e5-73e1-4b71-a7a1-e7653f6736dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SleepWeaver Advance Pediatric - Mask & Headgear - |
| Version Model Number | 101325 |
| Catalog Number | 101325 |
| Company DUNS | 012721295 |
| Company Name | CIRCADIANCE, 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-888-825-9640 |
| info@circadiance.com | |
| Phone | 1-888-825-9640 |
| info@circadiance.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B036101325 [Primary] |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
| B036101328 | SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Leopard |
| B036101327 | SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Camo |
| B036101326 | SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Pink |
| B036101325 | SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Blue |
| B036101324 | SleepWeaver Advance Pediatric Cloth Nasal PAP Mask & Headgear - Beige |