| Primary Device ID | 30093815801161 |
| NIH Device Record Key | 3d5f21cc-6a47-4206-b0a7-59716087245f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FreeStyle Precision H |
| Version Model Number | 80116 |
| Catalog Number | 80116 |
| 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 |
| Phone | +1(800)527-3339 |
| xx@xx.xx |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00093815801160 [Primary] |
| GS1 | 10093815801167 [Unit of Use] |
| GS1 | 30093815801161 [Package] Contains: 00093815801160 Package: Case [6 Units] In Commercial Distribution |
| NDC/NHRIC | 57599-0116-5 [Secondary] |
| LFR | Glucose dehydrogenase, glucose |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2016-07-22 |
| 30093815801161 | FreeStyle Precision H Blood Glucose Test Strips |
| 30093815711811 | FreeStyle Precision H Blood Glucose and Ketone Monitoring System |