This page includes the latest FDA filings for Omnis Health L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3006979609 |
| FEI Number | 3006979609 |
| Name | Omnis Health LLC |
| Owner & Operator | Omnis Health LLC |
| Contact Address | 1309 Elm Hill Pike Nashville TN 37210 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1309 Elm Hill Pike Nashville, TN 37210 US |
Device Company | Device | Date |
|---|---|---|
| OMNIS HEALTH, LLC | EmbraceWAVE+ Pre-Pack (3x24) APX04AB0400BTPR | 2023-03-31 |
| OMNIS HEALTH, LLC | Embrace Pen Needle 30G @5mm SHN02MM30.05 | 2022-12-07 |
| OMNIS HEALTH, LLC | Embrace Pen Needle 32G @4mm SHN02MM32.04 | 2022-12-07 |
| OMNIS HEALTH, LLC | Embrace Pen Needle 31G @8mm SHN02MM31.08 | 2022-12-07 |
| OMNIS HEALTH, LLC | Embrace Pen Needle 31G @5mm SHN02MM31.05 | 2022-12-07 |
| OMNIS HEALTH, LLC | Embrace Pen Needle 29G @12mm SHN02MM29.12 | 2022-12-07 |
| OMNIS HEALTH, LLC | Embrace Pen Needle 31G @6mm SHN02MM31.06 | 2022-12-07 |
| OMNIS HEALTH, LLC | Embrace Pen Needle 30G @8mm SHN02MM30.08 | 2022-12-07 |
| OMNIS HEALTH, LLC | HealthWise Embrace TALK Pre-Pack (3x15) APX03AB0313HWPR | 2022-11-04 |
| OMNIS HEALTH, LLC | Embrace Blood Glucose Monitor | 2021-10-01 |
| OMNIS HEALTH, LLC | Embrace Safety Lancet | 2021-07-13 |
| OMNIS HEALTH, LLC | Embrace Safety Lancet | 2021-07-13 |
| OMNIS HEALTH, LLC | Embrace Safety Lancet | 2021-07-13 |
| OMNIS HEALTH, LLC | Embrace Lancet | 2021-07-09 |
| OMNIS HEALTH, LLC | Embrace TALK Blood Glucose Monitor | 2019-12-18 |
| OMNIS HEALTH, LLC | Embrace TALK Blood Glucose Monitor (Pre-Pack) | 2019-12-10 |
| OMNIS HEALTH, LLC | HealthWise Embrace TALK Pre-Pack (3x12) | 2019-12-10 |
| OMNIS HEALTH, LLC | Embrace TALK 50 ct. test strip (Mail Order) | 2019-12-10 |
| OMNIS HEALTH, LLC | Embrace TALK 25 ct. test strip | 2019-12-10 |
| OMNIS HEALTH, LLC | Embrace TALK Control Solution L1 (LO) | 2019-12-10 |
| OMNIS HEALTH, LLC | HealthWise Embrace TALK Blood Glucose Test Strips (50 ct.) | 2019-12-10 |
| OMNIS HEALTH, LLC | HealthWise Embrace TALK Blood Glucose Monitoring System (Starter Kit) | 2019-12-10 |
| OMNIS HEALTH, LLC | HealthWise Embrace TALK Blood Glucose Monitoring System (Meter Only) | 2019-12-10 |
| OMNIS HEALTH, LLC | Embrace TALK 100 ct. test strip | 2019-12-10 |
| OMNIS HEALTH, LLC | Embrace TALK control solution HI | 2019-12-09 |
| OMNIS HEALTH, LLC | Embrace TALK 50 ct. test strip | 2019-11-06 |
| NCAGE Code | 4JVV4 | OMNIS HEALTH LLC |
| CAGE Code | 4JVV4 | OMNIS HEALTH, LLC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 201908226412 | Pusan,South Korea -> Savannah, Georgia | BLOOD GLUCOSE MONITORING SYSTEM 17-24PALLET, 157CTN PO 0010235 0010269 INV NO AMIOMN-190712-01 02 SCAC BANQ HBL# SEL6849083 | 491 CTN |
| 201908226412 | Pusan,South Korea -> Savannah, Georgia | BLOOD GLUCOSE MONITORING SYSTEM 1-16PALLET, 334CTN HS-CODE 902780 | 491 CTN |
| 2018120747786 | Pusan,South Korea -> Los Angeles, California | BLOOD GLUCOSE MONITORING SYSTEM AND PARTS ( AGM-4000 EMBRACE PRO ) TOTAL 18,000 VIAL INVOICE AMIOMN-181116-01 HS CODE 9027909099 9027801000 | 73 CTN |
| 2018111529861 | Pusan,South Korea -> Long Beach, California | BLOOD GLUCOSE MONITORING SYSTEM AND PARTS ( AGM-4000 EMBRACE PRO ) TOTAL 16,500 VIAL INVOICE AMIOMN-181018-01 HS CODE 9027909099 9027801000 | 68 CTN |
| 2018101232526 | Pusan,South Korea -> Long Beach, California | BLOOD GLUCOSE MONITORING SYSTEM AND PARTS ( AGM-4000 EMBRACE PRO ) TOTAL 18,000 VIAL INVOICE AMIOMN-180913-01 HS CODE 9027909099 9027801000 | 77 CTN |
| 2018091147646 | Pusan,South Korea -> Long Beach, California | BLOOD GLUCOSE MONITORING SYSTEM AND PARTS ( AGM-4000 EMBRACE PRO ) TOTAL 21,437 VIAL INVOICE AMIOMN-180816-01 HS CODE 9027909099 9027801000 | 84 CTN |
| 2018080158038 | Pusan,South Korea -> Long Beach, California | BLOOD GLUCOSE MONITORING SYSTEM AND PARTS ( AGM-4000 EMBRACE PRO ) TOTAL 15,000 VIAL INVOICE AMIOMN-180712-01 HS CODE 9027909099 9027801000 | 67 CTN |
| 2018071916909 | Pusan,South Korea -> Long Beach, California | BLOOD GLUCOSE MONITORING SYSTEM AND PARTS ( AGM-4000 EMBRACE PRO ) TOTAL 13,500 VIAL INVOICE AMIOMN-180614-01 HS CODE 9027909099 9027801000 | 57 CTN |
| 2018070366258 | Pusan,South Korea -> Long Beach, California | BLOOD GLUCOSE MONITORING SYSTEM AND PARTS ( AGM-4000 EMBRACE PRO ) TOTAL 13,500 VIAL INVOICE AMIOMN-180614-01 HS CODE 9027909099 9027801000 | 57 CTN |