Primary Device ID | 00894030002048 |
NIH Device Record Key | b0f41f79-8f19-4b6d-a905-26987fbf70db |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Embrace Lancet |
Version Model Number | SHN02GM0123 |
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 |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Needle Gauge | 30 Gauge |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00894030002048 [Primary] |
FMK | Lancet, Blood |
QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-07-09 |
Device Publish Date | 2021-07-01 |
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. |