| Primary Device ID | 00860003459850 |
| NIH Device Record Key | 6414509c-dfa7-4e87-8e9c-1dd145fe830a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eKare inSight |
| Version Model Number | EK001 |
| Company DUNS | 079302040 |
| Company Name | E-Kare Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com | |
| Phone | 844-443-5273 |
| info@ekareinc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860003459850 [Primary] |
| FXN | Tape, Camera, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-09 |
| Device Publish Date | 2022-12-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EKARE INSIGHT 86744994 5182447 Live/Registered |
Ekare Inc. 2015-09-02 |