| Primary Device ID | 00804084000150 |
| NIH Device Record Key | c57046e2-e176-406b-9c7a-2bb3277d6ce3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IDEAL LIFE Control Solution Level II |
| Version Model Number | GCS0104 |
| Company DUNS | 205155174 |
| Company Name | Ideal Life 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 | 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 | 1-888-433-2541 |
| info@ideallife.com |
| Weight | 5 Gram |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00804084000150 [Primary] |
| GS1 | 10804084000157 [Package] Package: [200 Units] In Commercial Distribution |
| GS1 | 20804084000154 [Package] Package: [100 Units] In Commercial Distribution |
| GS1 | 30804084000151 [Package] Package: [1 Units] In Commercial Distribution |
| GS1 | 40804084000158 [Package] Contains: 30804084000151 Package: [100 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 | 4 |
| Public Version Date | 2019-08-08 |
| Device Publish Date | 2019-07-17 |
| 10804084000010 - IDEAL LIFE BP-Manager™ | 2019-11-08 |
| 00804084000112 - IDEAL LIFE BP-Manager™ | 2019-11-08 BP Manager |
| 00804084000150 - IDEAL LIFE Control Solution Level II | 2019-08-08For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions contains a known amount of glucose that reacts with the test strips. |
| 00804084000150 - IDEAL LIFE Control Solution Level II | 2019-08-08 For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions |
| 00804084000143 - IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips) | 2019-08-07 |
| 10804084000065 - IDEAL LIFE SPO2 Manager™ | 2019-07-17 |
| 10804084000102 - IDEAL LIFE SPO2 Manager™ | 2019-07-17 |