DuraDiagnost
GUDID 00884838095205
Stationary x-ray system
Philips Healthcare (Suzhou) Co., Ltd.
Stationary basic diagnostic x-ray system, digital| Primary Device ID | 00884838095205 |
| NIH Device Record Key | 0597d8d6-7af7-484e-875d-034c4e64d481 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DuraDiagnost |
| Version Model Number | 712203 |
| Company DUNS | 421265537 |
| Company Name | Philips Healthcare (Suzhou) Co., Ltd. |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| mary.zhu@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com | |
| Phone | +1(800)722-9377 |
| shawn.guo@philips.com |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 1060 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 18 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838095205 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201640
FDA Product Code
| KPR | System, x-ray, stationary |
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 | 2020-09-14 |
| Device Publish Date | 2020-09-04 |
On-Brand Devices [DuraDiagnost]
| 00884838064751 | The DuraDiagnost is intended for use in generating radiographic images of human anatomy by quali |
| 00884838095205 | Stationary x-ray system |
Trademark Results [DuraDiagnost]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURADIAGNOST 79114722 4441771 Live/Registered |
Koninklijke Philips N.V. 2012-05-31 |
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