DEVICE: LUMISCOPE (M36811431)
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Device Identifier (DI) Information
LUMISCOPE
1143
In Commercial Distribution
GF HEALTH PRODUCTS, INC.
1143
In Commercial Distribution
GF HEALTH PRODUCTS, INC.
Automatic Wrist Blood Pressure Monitor
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 36551 | Patient monitoring system module, blood pressure, noninvasive |
A small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Humidity: less than 93 Percent (%) Relative Humidity |
| Storage Environment Temperature: between -4 and 131 Degrees Fahrenheit |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
32be2cf9-1389-43b0-8438-e4c1ae8a8c67
September 20, 2022
5
August 31, 2016
September 20, 2022
5
August 31, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| M36811432 | 8 | M36811431 | In Commercial Distribution | ||
| M36811433 | 48 | M36811432 | In Commercial Distribution |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
770-368-4700
cs@grahamfield.com
cs@grahamfield.com