Primary Device ID | B3437000A1 |
NIH Device Record Key | 7719b4d5-eb9d-4f81-99ec-03b2f859e073 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | POLY |
Version Model Number | 7000A |
Company DUNS | 002692106 |
Company Name | Medtek Lighting Corporation |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | true |
OTC Over-The-Counter | true |
Weight | 60 Pound |
Weight | 60 Pound |
Weight | 60 Pound |
Weight | 60 Pound |
Area/Surface Area | 800 Square centimeter |
Weight | 60 Pound |
Area/Surface Area | 800 Square centimeter |
Weight | 60 Pound |
Area/Surface Area | 800 Square centimeter |
Weight | 60 Pound |
Area/Surface Area | 800 Square centimeter |
Weight | 60 Pound |
Area/Surface Area | 800 Square centimeter |
Weight | 60 Pound |
Area/Surface Area | 800 Square centimeter |
Weight | 60 Pound |
Area/Surface Area | 800 Square centimeter |
Weight | 60 Pound |
Area/Surface Area | 800 Square centimeter |
Weight | 60 Pound |
Area/Surface Area | 800 Square centimeter |
Weight | 60 Pound |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B3437000A1 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-03-09 |
Device Publish Date | 2017-08-31 |
B3437000A1 - POLY | 2020-03-09LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Infrared (850nm). The wavelengths are available individually on treatment heads or a mix of wavelengths on the same treatment head. There is a Touch Screen Display for entering treatment times and selecting treatment heads. The unit is mounted on a base with casters for moving around a clinic. |
B3437000A1 - POLY | 2020-03-09 LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Infrared (850nm). The wavelengths are ava |
B343B100 - UVBioTek | 2018-12-21 Phototherapy Unit. UVB Narrowband. Single upright panel with 10 lamps. Mounts to wall or to stand. |
B343B1600 - UVBioTek | 2018-12-21 Phototherapy Unit. UVB Narrowband. 4 Connected Panels, attached to a wall, wrap around patient. 16 lamps, each 72" in height. |
B343B20 - UVBioTek | 2018-12-21 Phototherapy Unit. UVB Narrow Band. Single upright Panel with Two 72" Lamps. Mounts to Wall. |
B343B2400 - UVBioTek | 2018-12-21 Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 24 lamps, each 72" in height. Cl |
B343B3200 - UVBioTek | 2018-12-21 Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 32 Lamps, each 72" in height. Cl |
B343B40 - UVBioTek | 2018-12-21 Phototherapy Unit. UVB Narrowband. Single upright panel with Four 72" lamps. Mounts to wall or stand. |
B343B4000 - UVBioTek | 2018-12-21 Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 40 lamps, each 72" in height. Cl |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POLY 98202787 not registered Live/Pending |
Plantronics, Inc. 2023-09-28 |
POLY 98202750 not registered Live/Pending |
Plantronics, Inc. 2023-09-28 |
POLY 98129333 not registered Live/Pending |
Poly Inc 2023-08-11 |
POLY 97695965 not registered Live/Pending |
SEW-EURODRIVE GmbH & Co KG 2022-11-29 |
POLY 97611794 not registered Live/Pending |
Alpha Coffee, Inc. 2022-09-28 |
POLY 90900474 not registered Live/Pending |
POLY US, L.L.C. 2021-08-24 |
POLY 90883146 not registered Live/Pending |
Pal Labs Inc. 2021-08-14 |
POLY 88898516 not registered Live/Pending |
Kamel Greene 2020-05-03 |
POLY 88705904 not registered Live/Pending |
Google LLC 2019-11-25 |
POLY 88343347 not registered Live/Pending |
Plantronics, Inc. 2019-03-17 |
POLY 88343345 not registered Live/Pending |
Plantronics, Inc. 2019-03-17 |
POLY 88343344 not registered Live/Pending |
Plantronics, Inc. 2019-03-17 |