POWERLED
GUDID 03700712421113
PWD33S SHELTER RETROFIT KIT
MAQUET SAS
Operating room light| Primary Device ID | 03700712421113 |
| NIH Device Record Key | afe5f25d-d400-4e31-99b1-94b63cfb9f2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POWERLED |
| Version Model Number | ARD222201140A |
| Company DUNS | 264700139 |
| Company Name | MAQUET SAS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700712421113 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K070442
FDA Product Code
| FSY | Light, Surgical, Ceiling Mounted |
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 | 2022-10-27 |
| Device Publish Date | 2022-10-19 |
On-Brand Devices [POWERLED]
| 03700712405830 | PWD70+DF HOR SC07 K3 |
| 03700712405823 | PWD70+DF HOR R K3 |
| 03700712406103 | PWD33 S SHELTER |
| 03700712421113 | PWD33S SHELTER RETROFIT KIT |
Trademark Results [POWERLED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POWERLED 79023431 3356523 Live/Registered |
MAQUET S.A.S. 2006-03-31 |
 POWERLED 75232142 2127346 Dead/Cancelled |
MITSUBISHI CABLE AMERICA, INC. 1997-01-27 |
 POWERLED 73786389 1574543 Dead/Cancelled |
MITSUBISHI CABLE AMERICA, INC. 1989-03-13 |
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