Alice 1063547
GUDID 00606959020733
Alice 6 LDxN Headbox, International
Respironics, Inc.
Polysomnograph| Primary Device ID | 00606959020733 |
| NIH Device Record Key | f19a36f8-3fc2-45e2-ac4c-8b5307c3ec8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alice |
| Version Model Number | 1068717 |
| Catalog Number | 1063547 |
| Company DUNS | 080728314 |
| Company Name | Respironics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959020733 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K040595
FDA Product Code
| OLV | Standard polysomnograph with electroencephalograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2016-06-21 |
Devices Manufactured by Respironics, Inc.
| 00606959424852 - DreamStation BiPAP autoSV | 2025-08-12 DreamStation BiPAP autoSV with Humidifier, with Heated Tube, with Cell Modem, Australia |
| 00606959424944 - DreamStation BiPAP AVAPS | 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier, with Cell Modem, Australia |
| 00606959424951 - DreamStation BiPAP AVAPS | 2025-08-12 DreamStation BiPAP AVAPS30 AE with Cell Modem, Australia |
| 00606959424968 - DreamStation BiPAP AVAPS | 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humdifier, with Heated Tube, with Cell Modem, Australia |
| 00606959424975 - DreamStation BiPAP AVAPS | 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier with WiFi, Australia |
| 00606959424982 - DreamStation BiPAP AVAPS | 2025-08-12 DreamStation BiPAP AVAPS30 AE with WiFi, Australia |
| 00606959424999 - DreamStation BiPAP AVAPS | 2025-08-12 DreamStation BiPAP AVAPS30 AE with Humidifier, with Heated Tube, with WiFi, Australia |
| 00606959425378 - DreamStation | 2025-08-12 DreamStation BiPAP AVAPS 30 AAM with Humidifier and Heated Tube, no Bluetooth, China |
Trademark Results [Alice]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALICE 98589138 not registered Live/Pending |
Polysoft, LLC 2024-06-06 |
 ALICE 98459247 not registered Live/Pending |
Play Like Alice LLC 2024-03-20 |
 ALICE 98362142 not registered Live/Pending |
Leping Larry Han 2024-01-17 |
 ALICE 98001633 not registered Live/Pending |
Creative Mad Systems Inc. 2023-05-17 |
 ALICE 97458553 not registered Live/Pending |
Full Half Zero IP Pty Ltd 2022-06-14 |
 ALICE 97308819 not registered Live/Pending |
Zhang, Jianxiong 2022-03-11 |
 ALICE 97177889 not registered Live/Pending |
Xu, Yang 2021-12-17 |
 ALICE 97028311 not registered Live/Pending |
Rutt Capital LLC 2021-09-15 |
 ALICE 90879579 not registered Live/Pending |
The Mad Botter Inc. 2021-08-12 |
 ALICE 90686034 not registered Live/Pending |
Surprise.com, Inc. 2021-05-01 |
 ALICE 90578533 not registered Live/Pending |
DELGADILLO GUEVARA, Sergio Francisco 2021-03-15 |
 ALICE 90363794 not registered Live/Pending |
InMoment, Inc. 2020-12-07 |
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