iBloodPressure SM5000-IBAL
GUDID 00869876000053
iBloodPressure Cellular Blood Pressure Monitor, Adult, Large
SMART METER LLC
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist| Primary Device ID | 00869876000053 |
| NIH Device Record Key | ccff3091-5103-4171-9628-b9272f1bddc3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iBloodPressure |
| Version Model Number | SMBP802-GS-001 |
| Catalog Number | SM5000-IBAL |
| Company DUNS | 117014140 |
| Company Name | SMART METER LLC |
| 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 | true |
Device Dimensions
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
| Circumference | 42 Centimeter |
| Circumference | 22 Centimeter |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869876000053 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123780
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-07 |
| Device Publish Date | 2020-09-29 |
On-Brand Devices [iBloodPressure]
| 00869876000039 | iBloodPressure Cellular Blood Pressure Monitor, Adult, Large |
| 00869876000053 | iBloodPressure Cellular Blood Pressure Monitor, Adult, Large |
| 00869876000046 | iBloodPressure, Cellular, Blood Pressure Monitor |
Trademark Results [iBloodPressure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IBLOODPRESSURE 90090378 not registered Live/Pending |
Smart Meter LLC 2020-08-03 |
 IBLOODPRESSURE 90088160 not registered Live/Pending |
Smart Meter LLC 2020-08-02 |
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