FreeStyle InsuLinx 71228
GUDID 30699073712289
FreeStyle Insulinx Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
Glucose/ketone monitoring system IVD, home-use| Primary Device ID | 30699073712289 |
| NIH Device Record Key | dd1b5e53-82a2-4d7c-8c48-6ead9bf86e8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FreeStyle InsuLinx |
| Version Model Number | 71228 |
| Catalog Number | 71228 |
| Company DUNS | 966390890 |
| Company Name | ABBOTT DIABETES CARE INC |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx | |
| Phone | +1(800)222-3100 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00699073712288 [Primary] |
| GS1 | 10699073712285 [Unit of Use] |
| GS1 | 30699073712289 [Package] Contains: 00699073712288 Package: Case [16 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152328
FDA Product Code
| LFR | Glucose dehydrogenase, glucose |
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 | 2016-07-22 |
On-Brand Devices [FreeStyle InsuLinx]
| 30699073712319 | FreeStyle InsuLinx Blood Glucose Test Strips |
| 30699073712302 | FreeStyle InsuLinx Blood Glucose Test Strips |
| 30699073712296 | FreeStyle InsuLinx Blood Glucose Test Strips |
| 30699073712289 | FreeStyle Insulinx Blood Glucose Test Strips |
| 30699073712272 | FreeStyle InsuLinx Blood Glucose Test Strips |
| 30093815715000 | FreeStyle InsuLinx Blood Glucose Monitoring System |
| 30093815711507 | FreeStyle InsuLinx Blood Glucose Monitoring System |
| 00093815711452 | FreeStyle InsuLinx Blood Glucose Monitoring System |
| 30093815711439 | FreeStyle InsuLinx Blood Glucose Monitoring System |
| 30093815711422 | FreeStyle InsuLinx Blood Glucose Monitoring System |
Trademark Results [FreeStyle InsuLinx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FREESTYLE INSULINX 85457075 4211544 Live/Registered |
Abbott Diabetes Care Inc. 2011-10-26 |
 FREESTYLE INSULINX 85121682 4202869 Dead/Cancelled |
Abbott Diabetes Care Inc. 2010-09-02 |
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