| Primary Device ID | 00894030002659 |
| NIH Device Record Key | 918eab33-c0e6-4475-8b60-fedddbd06de2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Embrace Safety Lancet |
| Version Model Number | SHN02GX30.18 |
| Company DUNS | 824763358 |
| Company Name | OMNIS HEALTH, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | false |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Needle Gauge | 30 Gauge |
| Length | 1.8 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00894030002659 [Primary] |
| FMK | Lancet, Blood |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-13 |
| Device Publish Date | 2021-07-05 |
| 00894030002673 | Embrace Safety Lancet 23G/1.8mm 100ct. |
| 00894030002659 | Embrace Safety Lancet 30G/1.8mm 100ct. |
| 00894030002512 | Embrace Safety Lancet 21G/2.2mm 100ct. |