FreeStyle Lite 70827
GUDID 30699073708275
FreeStyle Lite Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
Glucose/ketone monitoring system IVD, home-use| Primary Device ID | 30699073708275 |
| NIH Device Record Key | a30628ea-d09f-44f0-93cb-6f0b12b599df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FreeStyle Lite |
| Version Model Number | 70827 |
| Catalog Number | 70827 |
| Company DUNS | 966390890 |
| Company Name | ABBOTT DIABETES CARE INC |
| Device Count | 100 |
| 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(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| xx@xx.xx | |
| Phone | +1(888)522-5226 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00699073708274 [Primary] |
| GS1 | 10699073708271 [Unit of Use] |
| GS1 | 30699073708275 [Package] Contains: 00699073708274 Package: Case [12 Units] In Commercial Distribution |
| GS1 | 40699073708272 [Package] Contains: 00699073708274 Package: Case [12 Units] In Commercial Distribution |
| NDC/NHRIC | 99073-0708-27 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092602
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 Lite]
| 30699073715013 | FreeStyle Lite Blood Glucose Monitoring System |
| 30699073710261 | FreeStyle Lite Blood Glucose Test Strips |
| 30699073708275 | FreeStyle Lite Blood Glucose Test Strips |
| 40699073708227 | FreeStyle Lite Blood Glucose Test Strips |
| 30699073708190 | FreeStyle Lite Blood Glucose Test Strips |
| 30699073708176 | FreeStyle Lite Blood Glucose Test Strips |
| 40699073708050 | FreeStyle Lite Blood Glucose Monitoring System |
| 30699073708046 | FreeStyle Lite Blood Glucose Monitoring System |
| 30699073000010 | FreeStyle Lite Blood Glucose Monitoring System |
| 00093815708292 | FreeStyle Lite Blood Glucose Monitoring System |
Trademark Results [FreeStyle Lite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FREESTYLE LITE 77384230 3488499 Live/Registered |
Abbott Diabetes Care Inc. 2008-01-30 |
 FREESTYLE LITE 77023119 3427434 Live/Registered |
Abbott Diabetes Care Inc. 2006-10-17 |
 FREESTYLE LITE 77022004 not registered Dead/Abandoned |
Abbott Laboratories 2006-10-16 |
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