Primary Device ID | B036100965 |
NIH Device Record Key | 9726d130-536d-4f56-a697-21e6ecc246a3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SleepWeaver Anew - Mask & Headgear - Large - Blue |
Version Model Number | 100965 |
Catalog Number | 100965 |
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 | B036100965 [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 |
B036100274 - SleepWeaver Advance - Mask & Headgear - Blue | 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Blue |
B036100277 - SleepWeaver Advance - Mask & Headgear - Pink | 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Pink |
B036100281 - SleepWeaver Advance - Mask & Headgear - Camo | 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Camo |
B036100285 - SleepWeaver Advance - Mask & Headgear - Leopard | 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Leopard |
B036100289 - SleepWeaver Advance - Mask Only - Blue | 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Blue |
B036100291 - SleepWeaver Advance - Mask Only - Pink | 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Pink |
B036100293 - SleepWeaver Advance - Mask Only - Camo | 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Camo |
B036100295 - SleepWeaver Advance - Mask Only - Leopard | 2018-07-06 SleepWeaver Advance Cloth Nasal CPAP Mask Only - Leopard |