LUMISCOPE
GUDID M36811333
Automatic Blood Pressure Monitor
GF HEALTH PRODUCTS, INC.
Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive Patient monitoring system module, blood pressure, noninvasive| Primary Device ID | M36811333 |
| NIH Device Record Key | 6d7abaa1-6e7f-4696-8ec4-c464ebc7fa28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LUMISCOPE |
| Version Model Number | 1133 |
| Company DUNS | 132016168 |
| Company Name | GF HEALTH PRODUCTS, 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com | |
| Phone | 770-368-4700 |
| cs@grahamfield.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M36811331 [Primary] |
| HIBCC | M36811332 [Package] Contains: M36811331 Package: [6 Units] In Commercial Distribution |
| HIBCC | M36811333 [Package] Contains: M36811332 Package: [4 Units] In Commercial Distribution |
FDA Product Code
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-08-27 |
| Device Publish Date | 2016-08-31 |
On-Brand Devices [LUMISCOPE]
| M36811372 | Advanced Upper Arm Blood Pressure Monitor |
| M368SW10002 | Standard TENS Unit |
| M368LUMITENS2 | Economy TENS Unit |
| M3682000T1 | Deluxe TENS Unit |
| M36811333 | Automatic Blood Pressure Monitor |
| M3682040061 | #NURSES STETH BLUE LOT# |
| M36867003 | Portable Ultrasonic Nebulizer |
| M36811431 | Automatic Wrist Blood Pressure Monitor |
Trademark Results [LUMISCOPE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUMISCOPE 76303432 2631187 Live/Registered |
GF HEALTH PRODUCTS, INC. 2001-08-23 |
 LUMISCOPE 73443255 1360572 Dead/Cancelled |
WOBBOT INTERNATIONAL LIMITED 1983-09-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.