PERFORMATRAK KR1023022
GUDID 00606959014886
PERFORMATRAK REUSABLE PACK, KOREA, MEDIUM
Respironics, Inc.
CPAP/BPAP face mask, reusable| Primary Device ID | 00606959014886 |
| NIH Device Record Key | 3bae468c-2b65-4288-9b3e-42aaa9808aa7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PERFORMATRAK |
| Version Model Number | 00 |
| Catalog Number | KR1023022 |
| 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 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| 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 Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959014886 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K002465
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 | 2018-08-20 |
| Device Publish Date | 2016-05-12 |
On-Brand Devices [PERFORMATRAK]
| 00606959014923 | PERFORMATRAK SE REUSABLE PACK, KOREA, LARGE |
| 00606959014916 | PERFORMATRAK SE REUSABLE PACK, KOREA, MEDIUM |
| 00606959014909 | PERFORMATRAK SE REUSABLE PACK, KOREA, SMALL |
| 00606959014893 | PERFORMATRAK REUSABLE PACK, KOREA, LARGE |
| 00606959014886 | PERFORMATRAK REUSABLE PACK, KOREA, MEDIUM |
| 00606959014879 | PERFORMATRAK REUSABLE PACK, KOREA, SMALL |
| 00606959011625 | PerformaTrak Full SE WCapstrap, Single, LARGE |
| 00606959011618 | PerformaTrak Full SE WCapstrap, Single, MEDIUM |
| 00606959011601 | PerformaTrak Full SE WCapstrap, Single, SMALL |
| 00606959009479 | PerformaTrak SE 4PT Headgear, China, Large |
| 00606959009462 | PerformaTrak SE 4PT Headgear, China, Medium |
| 00606959009455 | PerformaTrak SE 4PT Headgear, China, Small |
| 00606959009448 | PerformaTrak EE Leak1 4PT Headgear, China, Large |
| 00606959009431 | PerformaTrak EE Leak1 4PT Headgear, China, Medium |
| 00606959009424 | PerformaTrak EE Leak1 4PT Headgear, China, Small |
| 30606959007629 | Performatrak SE WHgr-Disp-Int, LARGE |
| 30606959007612 | Performatrak SE WHgr-Disp-Int, MEDIUM |
| 30606959007605 | Performatrak SE WHgr-Disp-Int, SMALL |
| 30606959007599 | Performatrak WHgr-Disp-Int, LARGE |
| 30606959007582 | Performatrak WHgr-Disp-Int, MEDIUM |
| 30606959007575 | Performatrak WHgr-Disp-Int, SMALL |
| 30606959007568 | PERFORMATRAK FULL SE W CAPSTRAP, LARGE |
| 30606959007551 | PERFORMATRAK FULL SE W CAPSTRAP, MEDIUM |
| 30606959007544 | PERFORMATRAK FULL SE W CAPSTRAP, SMALL |
| 00606959004245 | PerformaTrak Full WCapstrap, Single, LARGE |
| 00606959004238 | PerformaTrak Full WCapstrap, Single, MEDIUM |
| 00606959004221 | PerformaTrak Full WCapstrap, Single, SMALL |
| 30606959003294 | PTRAK FULL, FACE MASK WITH CAP STRAP, LARGE |
| 30606959003287 | PERFORMATRAK FULL w CAPSTRAP, MEDIUM |
| 30606959003270 | PERFORMATRAK FULL w CAPSTRAP,SMALL |
| 00606959000797 | Performatrak SE ReUSAble Pack, Int, LARGE |
| 00606959000780 | Performatrak SE ReUSAble Pack, Int, MEDIUM |
| 00606959000773 | Performatrak SE ReUSAble Pack, Int, SMALL |
| 30606959000712 | Performatrak SE WHgr-Disp-Dom, LARGE |
| 30606959000705 | Performatrak SE WHgr-Disp-Dom, MEDIUM |
| 30606959000699 | Performatrak SE WHgr-Disp-Dom, SMALL |
| 00606959000681 | Performatrak ReUSAble Pack, Int, LARGE |
| 00606959000674 | M Performatrak ReUSAble Pack, Int, MEDIUM |
| 00606959000667 | Performatrak ReUSAble Pack, Int, SMALL |
| 30606959000651 | Performatrak WHgr-Disp-Dom, LARGE |
| 30606959000644 | Performatrak WHgr-Disp-Dom, MEDIUM |
| 30606959000637 | Performatrak WHgr-Disp-Dom, SMALL |
| 00606959042599 | Philips SE Starter Kit, PerformaTrak and CapStrap |
| 00606959042582 | Philips SE Starter Kit, Oro-Nasal Package |
| 00606959042575 | Philips EE Starter Kit, Base Package |
| 00606959042568 | Philips Basic Kit, PerformaTrak SE, Dom |
| 00606959042551 | Philips Basic Kit, Performatrak SE, Intl |
| 00606959042544 | Philips Basic Kit, PerformaTrak and PerforMax, Dom |
| 30606959042514 | Philips Procedure, CapStrap with Filtered Exhalation Port, Small, SA |
| 30606959042507 | Philips Procedure, CapStrap with Filtered Exhalation Port , Medium, SA |
Trademark Results [PERFORMATRAK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERFORMATRAK 76551413 3015971 Live/Registered |
RIC Investments, LLC 2003-09-25 |
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