| Primary Device ID | 00894030002611 |
| NIH Device Record Key | 730d0361-6165-47c5-b3a0-08e1df9e006c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Embrace Blood Glucose Monitor |
| Version Model Number | APX01AB0200N |
| Company DUNS | 824763358 |
| Company Name | OMNIS HEALTH, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00894030002611 [Primary] |
| LFR | Glucose Dehydrogenase, Glucose |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-01 |
| Device Publish Date | 2021-09-23 |
| 00894030002277 - EmbraceWAVE+ Pre-Pack (3x24) | 2023-03-31 EmbraceWAVE+ Blood Glucose Meter x 3 EmbraceWAVE Blood Glucose Test Strips 50ct. x 24 |
| 00894030002031 - Embrace Pen Needle 30G @8mm | 2022-12-07 Insulin pen needle 30G 8mm 100 ct. |
| 00894030002055 - Embrace Pen Needle 31G @6mm | 2022-12-07 Insulin pen needle 31G 6mm 100 ct. |
| 00894030002109 - Embrace Pen Needle 29G @12mm | 2022-12-07 Insulin pen needle 29G 12mm 100 ct. |
| 00894030002116 - Embrace Pen Needle 31G @5mm | 2022-12-07 Insulin pen needle 31G 5mm 100 ct. |
| 00894030002123 - Embrace Pen Needle 31G @8mm | 2022-12-07 Insulin pen needle 31G 8mm 100 ct. |
| 00894030002130 - Embrace Pen Needle 32G @4mm | 2022-12-07 Insulin pen needle 32G 4mm 100 ct. |
| 00894030002529 - Embrace Pen Needle 30G @5mm | 2022-12-07 Insulin pen needle 30G 5mm 100 ct. |