| Primary Device ID | 10885325000051 |
| NIH Device Record Key | 28113c9e-24d3-4add-b97a-c2af05164c98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CareSens N (MedPoint Diagnostics) |
| Version Model Number | 155104 |
| Company DUNS | 688840958 |
| Company Name | i-SENS, 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 |
| Phone | 1-866-563-3764 |
| customerservice@medpointdiagnostics.com | |
| Phone | 1-866-563-3764 |
| customerservice@medpointdiagnostics.com |
| Storage Environment Temperature | Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33.8 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885325000054 [Primary] |
| GS1 | 10885325000051 [Package] Contains: 00885325000054 Package: Case Pack (Mid-Box) [50 Units] In Commercial Distribution |
| GS1 | 20885325000058 [Package] Package: Master Case Carton [10 Units] In Commercial Distribution |
| GS1 | 50885325000059 [Unit of Use] |
| CGA | Glucose Oxidase, Glucose |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
| 10885325000051 | CareSens N Blood Glucose Test Strip |
| 10885325000044 | CareSens N Blood Glucose Meter |