Primary Device ID | 30357599821013 |
NIH Device Record Key | 4e8c3430-68a4-4130-9979-691c9455e270 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FreeStyle Libre 3 |
Version Model Number | 72078 |
Catalog Number | 72078 |
Company DUNS | 966390890 |
Company Name | ABBOTT DIABETES CARE INC |
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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
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 | true |
OTC Over-The-Counter | false |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx | |
Phone | +1(855)632-8658 |
xx@xx.xx |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00357599821012 [Primary] |
GS1 | 30357599821013 [Package] Contains: 00357599821012 Package: Case [4 Units] In Commercial Distribution |
QBJ | Integrated Continuous Glucose Monitoring system, factory calibrated |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-03 |
Device Publish Date | 2025-06-25 |
30357599819003 | FreeStyle Libre 3 Sensor Kit NFRS |
30357599818006 | FreeStyle Libre 3 Sensor Kit US |
57599-0820-00 | FreeStyle Libre 3 Continuous Glucose Monitoring System Reader |
30357599842001 | FreeStyle Libre 3 Continuous Glucose Monitoring System Reader |
30357599821013 | FreeStyle Libre 3 Continuous Glucose Monitoring System Reader |