DreamWisp 1137948
GUDID 00606959051164
Small, DreamWisp Nasal, Small-Medium-Large Connector WithHeadgear, Japan
Respironics, Inc.
CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable| Primary Device ID | 00606959051164 |
| NIH Device Record Key | 722bfe82-c1c1-4c45-a442-e575b8cc9f28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DreamWisp |
| Version Model Number | 00 |
| Catalog Number | 1137948 |
| 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 -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 | 00606959051164 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140980
FDA Product Code
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-04 |
| Device Publish Date | 2019-02-01 |
On-Brand Devices [DreamWisp]
| 00606959051096 | DreamWisp Nasal Mask, Extra Large with Medium Connector and Headgear, Global |
| 00606959051089 | DreamWisp Nasal Mask, Large with Medium Connector snf Headgear, Global |
| 00606959051072 | DreamWisp Nasal Mask, Medium with Medium Connector and Headgear, Global |
| 00606959051065 | DreamWisp Nasal, Small with Medium Connector, With Headgear, Global |
| 00606959051058 | DreamWisp Nasal, Petite with Medium Connector, With Headgear, Global |
| 00606959051034 | DreamWisp Nasal, Large with Medium Connector, Without Headgear, Global |
| 00606959051027 | DreamWisp Nasal Mask, Medium with Medium Connector, Without Headgear, Global |
| 00606959051010 | Small, DreamWisp Nasal, Medium Connector Without Headgear Global |
| 00606959051003 | DreamWisp Nasal Mask, Petite with Medium Connector Without Headgear, Global |
| 00606959050983 | FitPack, DreamWisp Nasal Mask with Medium Connector without Headgear, Global |
| 00606959051041 | DreamWisp Nasal, Extra Large with Medium Connecto,r Without Headgear, Global |
| 00606959050976 | FitPack, DreamWisp Nasal, Medium Connector with Headgear, Global |
| 00606959054493 | Extra Large, DreamWisp Nasal, SmallMedium Connector, WithHeadgear, Korea |
| 00606959054486 | Large, DREAMWISP Nasal, SmallMedium CONNECTOR, WithHeadgear, Korea |
| 00606959054479 | Medium, DREAMWISP Nasal, SmallMedium CONNECTOR, WithHeadgear, Korea |
| 00606959054462 | Small, DREAMWISP Nasal, SmallMedium CONNECTOR WithHeadgear, Korea |
| 00606959054455 | Petite, DreamWisp Nasal, SmallMedium CONNECTOR, WithHeadgear, Korea |
| 00606959051225 | PetiteExtra Large LabPack, DREAMWISP LAB PACK, SmallLarge Connectors |
| 00606959051218 | LABPACK, DREAMWISP, ALL Connectors, SmallMediumLarge Cushions WithHeadgear |
| 00606959051140 | Extra Large, DreamWisp Nasal, Medium Connector WithHeadgear, International |
| 00606959051133 | Large, DreamWisp Nasal, Medium Connector withHeadgear, International |
| 00606959051126 | Medium, DreamWisp Nasal, Medium Connector withHeadgear, International |
| 00606959051119 | Small, DreamWisp Nasal, Medium Connector withHeadgear, International |
| 00606959051102 | Petite, DreamWisp Nasal, Medium Connector withHeadgear, International |
| 00606959050990 | FitPack, DreamWisp Nasal, Medium Connector withHeadgear International |
| 00606959057371 | Extra Large, DreamWisp Nasal, Medium Connector withHeadgear, Russia and Central Asia |
| 00606959057364 | Large, DreamWisp Nasal, Medium Connector withHeadgear, Russia and Central Asia |
| 00606959057357 | Medium, DreamWisp Nasal, Medium Connector withHeadgear, Russia and Central Asia |
| 00606959057340 | Small, DreamWisp Nasal, Medium Connector withHeadgear, Russia and Central Asia |
| 00606959057333 | Petite, DreamWisp Nasal, Medium Connector withHeadgear, Russia and Central Asia |
| 00606959057326 | Extra Large, DreamWisp Nasal, Medium Connector withHeadgear, CentralEastern Europe |
| 00606959057319 | Large, DreamWisp Nasal, Medium Connector withHeadgear, CentralEastern Europe |
| 00606959057302 | Medium, DreamWisp Nasal, Medium Connector withHeadgear, CentralEastern Europe |
| 00606959057296 | Small, DreamWisp Nasal, Medium Connector withHeadgear, CentralEastern Europe |
| 00606959057289 | Petite, DreamWisp Nasal, Medium Connector withHeadgear, CentralEastern Europe |
| 00606959057272 | Extra Large, DreamWisp Nasal, Medium Connector withHeadgear, Asia Pacific |
| 00606959057265 | Large, DreamWisp Nasal, Medium Connector withHeadgear, Asia Pacific |
| 00606959057258 | Medium, DreamWisp Nasal, Medium Connector withHeadgear, Asia Pacific |
| 00606959057241 | Small, DreamWisp Nasal, Medium Connector withHeadgear, Asia Pacific |
| 00606959057234 | Petite, DreamWisp Nasal, Medium Connector withHeadgear, Asia Pacific |
| 00606959051195 | Extra Large, DreamWisp Nasal, Small-Medium-Large Connector WithHeadgear, Japan |
| 00606959051188 | Large, DreamWisp Nasal, Small-Medium-Large Connector WithHeadgear, Japan |
| 00606959051171 | Medium, DreamWisp Nasal, Small-Medium-Large Connector, WithHeadgear, Japan |
| 00606959051164 | Small, DreamWisp Nasal, Small-Medium-Large Connector WithHeadgear, Japan |
| 00606959051157 | Petite, DreamWisp Nasal, Small-Medium-Large Connector With Headgear, Japan |
Trademark Results [DreamWisp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DREAMWISP 79235968 5688294 Live/Registered |
Koninklijke Philips N.V. 2018-06-04 |
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