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. |
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 |