| Primary Device ID | B726BT0051 |
| NIH Device Record Key | 4ce4f4b0-859e-484b-b3ca-cb008733204c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BodyTrace |
| Version Model Number | BT005 |
| Company DUNS | 116841525 |
| Company Name | BODYTRACE, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | false |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 105 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B726BT0050 [Primary] |
| HIBCC | B726BT0051 [Package] Contains: B726BT0050 Package: Individual box [1 Units] In Commercial Distribution |
| HIBCC | B726BT0052 [Package] Package: 5-piece carton [5 Units] In Commercial Distribution |
| FRI | Scale, Stand-On, Patient |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-14 |
| Device Publish Date | 2020-07-06 |
| B726BT1042 | Upper arm blood pressure monitor. |
| B726BT1051 | Upper arm blood pressure monitor. |
| B726BT0051 | Weight scale. |
| B726BT1061 | Upper arm blood pressure monitor. |
| B726BT0061 | Weight scale. |
| B726BT007B1 | Weight scale. |
| B726BT007A1 | Weight scale. |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BODYTRACE 86975210 4594550 Live/Registered |
BodyTrace Holdings Limited 2013-09-13 |
![]() BODYTRACE 86063919 5191506 Live/Registered |
BodyTrace Holdings Limited 2013-09-13 |
![]() BODYTRACE 77719181 3791305 Live/Registered |
BODYTRACE HOLDINGS LIMITED 2009-04-21 |