AMARA CN1090220
GUDID 00606959025141
AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, PETITE
Respironics, Inc.
CPAP/BPAP face mask, reusable| Primary Device ID | 00606959025141 |
| NIH Device Record Key | 3235b401-06b2-4a8f-8017-0fba162ab6e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMARA |
| Version Model Number | 00 |
| Catalog Number | CN1090220 |
| Company DUNS | 080728314 |
| Company Name | Respironics, Inc. |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959025141 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082866
FDA Product Code
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
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 | 2017-02-10 |
On-Brand Devices [AMARA]
| 00606959022973 | 00 |
| 00606959022966 | 00 |
| 00606959022959 | 00 |
| 00606959015036 | AMARA MASK SE WITH RS FRAME AND HEADGEAR INTL, LARGE |
| 00606959015029 | AMARA MASK SE WITH RS FRAME AND HEADGEAR INTL, MEDIUM |
| 00606959015012 | AMARA MASK SE WRS FRAME AND RS HEADGEAR INTL, SMALL |
| 00606959015005 | AMARA MASK SE WRS FRAME AND RS HEADGEAR INTL, PETITE |
| 00606959014992 | AMARA MASK WITH RS FRAME AND HEADGEAR INTL, LARGE |
| 00606959014985 | AMARA MASK WITH RS FRAME AND HEADGEAR INTL, MEDIUM |
| 00606959014978 | AMARA MASK WITH RS FRAME AND RS HEADGEAR INTL, SMALL |
| 00606959014961 | AMARA MASK WITH RS FRAME AND RS HEADGEAR INTL, PETITE |
| 00606959014459 | AMARA STARTER KIT, PETITE |
| 00606959014374 | AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, PETITE |
| 00606959013902 | Amara FitPack |
| 00606959012899 | AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, MEDIUM |
| 00606959012851 | AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, SMALL |
| 00606959012653 | AMARA MASK WITH RS FRAME AND HEADGEAR DOM, LARGE |
| 00606959012646 | AMARA MASK WITH RS FRAME AND HEADGEAR DOM, MEDIUM |
| 00606959009325 | 00 |
| 00606959007192 | AMARA HEADGEAR - RP |
| 00606959007185 | AMARA HEADGEAR, RS, RP |
| 00606959007154 | AMARA CUSHION, RP-LARGE |
| 00606959007147 | AMARA CUSHION, RP-MEDIUM |
| 00606959007130 | AMARA CUSHION, RP - SMALL |
| 00606959007123 | AMARA CUSHION, RP - PETITE |
| 00606959006508 | AMARA MASK WITH RS FRAME AND RS HEADGEAR DOM, SMALL |
| 00606959006492 | AMARA MASK W RS FRAME AND RS HEADGEAR DOM, PETITE |
| 00606959025219 | AMARA MASK SE WITH RS FRAME AND HEADGEAR CHINA, LARGE |
| 00606959025202 | AMARA MASK SE WITH RS FRAME AND HEADGEAR CHINA, MEDIUM |
| 00606959025196 | AMARA MASK SE WITH RS FRAME AND RS HEADGEAR CHINA, SMALL |
| 00606959025189 | AMARA MASK SE WITH RS FRAME AND RS HEADGEAR CHINA, PETITE |
| 00606959025172 | AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, LARGE |
| 00606959025165 | AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, MEDIUM |
| 00606959025158 | AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, SMALL |
| 00606959025141 | AMARA MASK WITH RS FRAME AND HEADGEAR CHINA, PETITE |
| 00606959025134 | AMARA MASK SE WITH RS FRAME AND HEADGEAR JPN, LARGE |
| 00606959025127 | AMARA MASK SE WITH RS FRAME AND HEADGEAR JPN, MEDIUM |
| 00606959025110 | AMARA MASK SE WITH RS FRAME AND RS HEADGEAR JPN, SMALL |
| 00606959025103 | AMARA MASK SE WITH RS FRAME AND RS HEADGEAR JPN, PETITE |
| 00606959025097 | AMARA MASK WITH RS FRAME AND HEADGEAR JPN, LARGE |
| 00606959025080 | AMARA MASK WITH RS FRAME AND HEADGEAR JPN, AMARA |
| 00606959025073 | AMARA MASK WITH RS FRAME AND RS HEADGEAR JPN, SMALL |
| 00606959025066 | AMARA MASK WITH RS FRAME AND RS HEADGEAR JPN, PETITE |
| 00606959024946 | AMARA STARTER KIT, LARGE |
| 00606959024939 | AMARA STARTER KIT, MEDIUM |
| 00606959024922 | AMARA STARTER KIT, SMALL |
| 00606959024892 | AMARA MASK WITH RS FRAME WITHOUT HEADGEAR DOM, LARGE |
| 00606959024748 | Amara View Mask with headgear, XS, Japan |
Trademark Results [AMARA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMARA 98365564 not registered Live/Pending |
Perfume Attraction LLC 2024-01-19 |
 AMARA 98124496 not registered Live/Pending |
BioConsortia, Inc. 2023-08-09 |
 AMARA 97339983 not registered Live/Pending |
Khatchadoorian, Karekin 2022-03-31 |
 AMARA 90874565 not registered Live/Pending |
Branson, Shemika 2021-08-10 |
 AMARA 90570981 not registered Live/Pending |
Amara LLC 2021-03-10 |
 AMARA 88440295 not registered Live/Pending |
Echols, Daniel David 2019-05-21 |
 AMARA 88077995 not registered Live/Pending |
ProteÃna Animal, S.A. de C.V. 2018-08-14 |
 AMARA 87719816 5519014 Live/Registered |
ALRA 05 LLC 2017-12-13 |
 AMARA 87254641 not registered Live/Pending |
Amara Living Limited 2016-12-02 |
 AMARA 87174402 not registered Dead/Abandoned |
Quoc N. Tran 2016-09-16 |
 AMARA 87060735 5297538 Live/Registered |
TRANSFORM SR BRANDS LLC 2016-06-06 |
 AMARA 86869800 5167813 Live/Registered |
Crowns Of The People, Inc. 2016-01-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.