FreeStyle Precision Neo 71579
GUDID 30093815715796
FreeStyle Precision Neo Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
Glucose/ketone monitoring system IVD, home-use| Primary Device ID | 30093815715796 |
| NIH Device Record Key | 2cd8966c-2185-4656-8e4c-7751f4521ad2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FreeStyle Precision Neo |
| Version Model Number | 71579 |
| Catalog Number | 71579 |
| Company DUNS | 966390890 |
| Company Name | ABBOTT DIABETES CARE INC |
| Device Count | 50 |
| 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)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx | |
| Phone | +1(800)527-3339 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00093815715795 [Primary] |
| GS1 | 10093815715792 [Unit of Use] |
| GS1 | 30093815715796 [Package] Contains: 00093815715795 Package: Case [12 Units] In Commercial Distribution |
| GS1 | 40093815715793 [Package] Contains: 00093815715795 Package: Case [12 Units] In Commercial Distribution |
| NDC/NHRIC | 57599-1579-4 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142928
FDA Product Code
| NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER |
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 Precision Neo]
| 30357599000357 | FreeStyle Precision Neo Blood Glucose Test Strips |
| 30357599000340 | FreeStyle Precision Neo Blood Glucose Test Strips |
| 30357599000333 | FreeStyle Precision Neo Blood Glucose Test Strips Not For Retail Sale |
| 30357599000302 | FreeStyle Precision Neo Blood Glucose Monitoring System Not For Retail Sale |
| 30093815751756 | FreeStyle Precision Neo Blood Glucose Monitoring System |
| 30093815715819 | FreeStyle Precision Neo Blood Glucose Test Strips |
| 30093815715796 | FreeStyle Precision Neo Blood Glucose Test Strips |
| 30093815715772 | FreeStyle Precision Neo Blood Glucose Test Strips |
Trademark Results [FreeStyle Precision Neo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FREESTYLE PRECISION NEO 85765080 4881888 Live/Registered |
Abbott Diabetes Care Inc. 2012-10-26 |
 FREESTYLE PRECISION NEO 85600355 4889772 Live/Registered |
Abbott Diabetes Care Inc. 2012-04-17 |
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