MOCACuff
GUDID 00850842006056
MOCACARE CORP.
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist| Primary Device ID | 00850842006056 |
| NIH Device Record Key | 73dfa33a-f434-47ee-9e63-3ad808156cdb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MOCACuff |
| Version Model Number | HL168KF |
| Company DUNS | 079824513 |
| Company Name | MOCACARE CORP. |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850842006056 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113239
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 | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-12-09 |
On-Brand Devices [MOCACuff]
| 00850842006063 | MOCACuff (HL168KF) uses the oscillometric method to automatically measure systolic and diastolic |
| 00850842006056 | HL168KF |
Trademark Results [MOCACuff]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOCACUFF 87940196 5648777 Live/Registered |
MOCACARE Corp 2018-05-29 |
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