| Primary Device ID | 10885325000044 |
| NIH Device Record Key | f2599f34-3644-4a45-ab94-17e66db32e82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CareSens N (MedPoint Diagnostics) |
| Version Model Number | 155300-201 |
| Company DUNS | 688840958 |
| Company Name | i-SENS, Inc. |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885325000047 [Primary] |
| GS1 | 10885325000044 [Package] Contains: 00885325000047 Package: Master Case Carton [60 Units] In Commercial Distribution |
| NBW | System, Test, Blood Glucose, Over The Counter |
| 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 |