FreeStyle Libre 71701
GUDID 30357599000227
FreeStyle Libre Reader Kit US
ABBOTT DIABETES CARE INC
Percutaneous glucose monitoring system| Primary Device ID | 30357599000227 |
| NIH Device Record Key | 550ea8dd-bb3a-4f45-815e-c52fe633394b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FreeStyle Libre |
| Version Model Number | 71701 |
| Catalog Number | 71701 |
| Company DUNS | 966390890 |
| Company Name | ABBOTT DIABETES CARE INC |
| 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 | 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 |
Customer Support Contacts
| 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 | |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 70000 KiloPascal and 106000 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00357599000226 [Primary] |
| GS1 | 30357599000227 [Package] Contains: 00357599000226 Package: Case [4 Units] In Commercial Distribution |
| NDC/NHRIC | 57599-0000-22 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160030
FDA Product Code
| PZE | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-11-20 |
On-Brand Devices [FreeStyle Libre]
| 30357599000852 | FS Libre Sensor Kit |
| 30357599000470 | FreeSyle Libre Software CD |
| 30357599000241 | FreeStyle Libre Reader Kit US DOD |
| 30357599000227 | FreeStyle Libre Reader Kit US |
| 30357599000210 | FreeStyle Libre Reader Kit US |
| 30357599000203 | FreeStyle Libre Sensor Kit |
| 30357599000197 | FreeStyle Libre Sensor Kit |
Trademark Results [FreeStyle Libre]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FREESTYLE LIBRE 87429782 5531286 Live/Registered |
Abbott Diabetes Care Inc. 2017-04-28 |
 FREESTYLE LIBRE 87429781 5500523 Live/Registered |
Abbott Diabetes Care Inc. 2017-04-28 |
 FREESTYLE LIBRE 86063019 not registered Dead/Abandoned |
Abbott Diabetes Care Inc. 2013-09-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.