| Primary Device ID | 10885325001683 |
| NIH Device Record Key | f3ef65fa-c88d-4cd1-8b47-888198d7b763 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CareSens N Feliz BT |
| Version Model Number | 164508 |
| 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 | 1-800-429-5001 |
| cs1@i-sens.com | |
| Phone | 1-800-429-5001 |
| cs1@i-sens.com | |
| Phone | 1-800-429-5001 |
| cs1@i-sens.com | |
| Phone | 1-800-429-5001 |
| cs1@i-sens.com | |
| Phone | 1-800-429-5001 |
| cs1@i-sens.com | |
| Phone | 1-800-429-5001 |
| cs1@i-sens.com | |
| Phone | 1-800-429-5001 |
| cs1@i-sens.com | |
| Phone | 1-800-429-5001 |
| cs1@i-sens.com | |
| Phone | 1-800-429-5001 |
| cs1@i-sens.com |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885325001686 [Primary] |
| GS1 | 10885325001683 [Package] Contains: 00885325001686 Package: Master Case Carton [50 Units] In Commercial Distribution |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-26 |
| Device Publish Date | 2022-07-18 |
| 10885325000853 - KetoSens | 2023-08-03 KetoSens B-Ketone Monitoring System with Lancets |
| 10885325001492 - KetoSens | 2023-08-03 KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) |
| 10885325001188 - CareSens S Fit BT | 2023-07-19 CareSens S Fit BT Blood Glucose Monitoring System |
| 00885325001518 - CareSens S Fit | 2023-07-19 CareSens S Fit Blood Glucose Monitoring System |
| 10885325001768 - CareSens N Voice Square | 2023-07-19 CareSens N Voice Square Blood Glucose Monitoring System |
| 10885325001683 - CareSens N Feliz BT | 2022-07-26CareSens N Feliz BT Blood Glucose Monitoring System |
| 10885325001683 - CareSens N Feliz BT | 2022-07-26 CareSens N Feliz BT Blood Glucose Monitoring System |
| 10885325001690 - CareSens N Feliz | 2022-07-26 CareSens N Feliz Blood Glucose Monitoring System |
| 10885325001386 - Tempo | 2021-02-25 Tempo Blood Glucose Monitoring System |