| Primary Device ID | 00606959038479 |
| NIH Device Record Key | c6c4a0fd-2321-421f-baf7-6c89c070e5e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dorma 200 |
| Version Model Number | 207V |
| Catalog Number | 207V |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Phone | +1(724)387-4000 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| RESPIRONICS.SERVICE@PHILIPS.COM |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959038479 [Primary] |
| BZD | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-17 |
| Device Publish Date | 2019-04-09 |
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| 00606959012660 | Dorma 200, Australia |
| 00606959007413 | Dorma 200 with Humidifier, Domestic |
| 00606959006959 | Dorma 200 Domestic |
| 00606959038608 | Dorma 200 with Humidifier, China |
| 00606959038585 | Dorma 200 with Humidifier, Canada |
| 00606959038578 | Dorma 200, Canada |
| 00606959038486 | Dorma 200 CPAP System, Brazil |
| 00606959038462 | Dorma 200 Flow Generator, International |
| 00606959038455 | Dorma 200 Flow Generator, Canada |
| 00606959038448 | Dorma 200 Flow Generator, Domestic |
| 00606959037045 | Dorma 200 with Humidifier, LD |
| 00606959037038 | Dorma 200, LD |
| 00606959036970 | Dorma 200 with Humidifier, LA |
| 00606959036963 | Dorma 200, LA |
| 00606959036901 | Dorma 200 with Humidifier, International |
| 00606959036895 | Dorma 200, International |
| 00606959036802 | Dorma 200 with Humidifier, France |
| 00606959036796 | Dorma 200, France |
| 00606959036727 | Dorma 200 with Humidifier, AH |
| 00606959036710 | Dorma 200, AH |
| 00606959038479 | Dorma 200 CPAP System, China |
| 00606959040427 | Dorma 200, with Humidifier, Pico, China |