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OMNIS HEALTH, LLC

Last updated May 23, 2026

What OMNIS HEALTH, LLC makes

The company manufactures single-use blood lancets for home or point-of-care glucose monitoring, along with autoinjector needles designed for insulin delivery. It also produces blood glucose test strips in various pack sizes, including refill bundles for gestational diabetes, as well as all-in-one blood glucose monitoring systems combining meters, strips, and control solutions. Additional offerings include standalone glucose meters and pre-assembled meter kits with test strips.

These devices are classified under FDA regulations as Class I and Class II medical instruments, with most entries listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates within the United States, adhering to domestic regulatory requirements for in vitro diagnostics (IVDs) and reusable/non-reusable sharps.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 824763358

Catalogue (61)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Embrace Safety Lancet	SHN02GX23.18	FDA UDI	Class II	Active
EmbraceWAVE Blood Glucose Test Strips 25 ct.	APX04AB0403	FDA UDI	Class II	Active
Embrace TALK 50 ct. test strip (Mail Order)	APX03AB0303MO	FDA UDI	Class II	Active
Embrace Pen Needle 32G @4mm	SHN02MM32.04	FDA UDI	Class II	Active
Embrace Safety Lancet	SHN02GX30.18	FDA UDI	Class II	Active
Embrace EVO Mini Meter, all-in-one kit, RETAIL	APX01AB0851	FDA UDI	Class II	Active
Embrace TALK 100 ct. test strip	APX03AB0304	FDA UDI	Class II	Active
Embrace Meter Kit (w/10 ct)	APX01AB0300	FDA UDI	Class II	Active
Embrace Gestational Diabetes - Strips Refill Bundle (4 vials)	APX02GS0202RF	FDA UDI	Class II	Active
Embrace Pen Needle 30G @5mm	SHN02MM30.05	FDA UDI	Class II	Active
Embrace Strips, 10-ct	APX02AB0200	FDA UDI	Class II	Active
Embrace EVO Control Solution, L2 (Medium)	APX02AB0811	FDA UDI	Class I	Active
EmbraceEVO Gestational Diabetes Package - SMALL (5 vials)	APX01GS0100-S	FDA UDI	Class II	Active
HealthWise Embrace TALK Pre-Pack (3x12)	APX03AB0312HWPR	FDA UDI	Class II	Active
HealthWise Embrace TALK Pre-Pack (3x15)	APX03AB0313HWPR	FDA UDI	Class II	Active
Embrace Lancet	SHN02GM0123	FDA UDI	Class II	Active
EmbraceWAVE Glucose Control Solution High (L2)	APX04AB0407	FDA UDI	Class I	Active
Embrace EVO Strips, 50ct Vial - RETAIL	APX02AB0802	FDA UDI	Class II	Active
Embrace Control Solution Hi	APX02AB0511	FDA UDI	Class II	Active
EmbraceWAVE+ Pre-Pack (3x24)	APX04AB0400BTPR	FDA UDI	Class II	Active
Embrace Gestational Diabetes Package - SMALL (5 vials)	APX01GS0200-S	FDA UDI	Class II	Active
Embrace Strips, 50ct Vial - Mail Order (Yellow Band)	APX02AB0202MO	FDA UDI	Class II	Active
Embrace Meter, Meter Only	APX01AB200	FDA UDI	Class II	Active
EmbraceEVO Gestational Diabetes Package - LARGE (9 vials)	APX01GS0100-L	FDA UDI	Class II	Active
Embrace Meter Value Pack (incl. 50ct)	APX01AK0200VK	FDA UDI	Class II	Active
Embrace Blood Glucose Monitor	APX01AB0200N	FDA UDI	Class II	Active
Embrace Gestational Diabetes Package - LARGE (9 vials)	APX01GS0200-L	FDA UDI	Class II	Active
Embrace Value Kit (50ct Included)	APX01AB0500VK	FDA UDI	Class II	Active
Embrace TALK Blood Glucose Monitor (Pre-Pack 3 x 15)	APX03AB0301PRE	FDA UDI	Class II	Active
Embrace EVO Control Solution, L1 (Low)	APX02AB0810	FDA UDI	Class I	Active
Embrace Pen Needle 29G @12mm	SHN02MM29.12	FDA UDI	Class II	Active
Embrace Pen Needle 30G @8mm	SHN02MM30.08	FDA UDI	Class II	Active
HealthWise Embrace TALK Blood Glucose Test Strips (50 ct.)	APX03AB0314HW	FDA UDI	Class II	Active
EmbraceWAVE Blood Glucose Test Strips 50 ct.	APX04AB0404	FDA UDI	Class II	Active
EmbraceWAVE Glucose Control Solution Low (L1)	APX04AB0406	FDA UDI	Class I	Active
Embrace TALK 25 ct. test strip	AXP03AB0319	FDA UDI	Class II	Active
HealthWise Embrace TALK Blood Glucose Monitoring System (Starter Kit)	APX03AB0313HW	FDA UDI	Class II	Active
Embrace TALK Blood Glucose Monitor (Pre-Pack)	APX03AB0300PRE	FDA UDI	Class II	Active
HealthWise Embrace TALK Blood Glucose Monitoring System (Meter Only)	APX03AB0312HW	FDA UDI	Class II	Active
EmbraceWAVE+ Blood Glucose Meter	APX04AB0400BT	FDA UDI	Class II	Active
Embrace Pen Needle 31G @8mm	SHN02MM31.08	FDA UDI	Class II	Active
Embrace TALK control solution HI	APX03AB0317	FDA UDI	Class I	Active
Embrace Pen Needle 31G @6mm	SHN02MM31.06	FDA UDI	Class II	Active
Embrace TALK Control Solution L1 (LO)	APX03AB0318	FDA UDI	Class I	Active
Embrace Control Solution, L1 (Low)	APX02AB310	FDA UDI	Class I	Active
EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials)	APX01AGS0100-SR	FDA UDI	Class II	Active
Embrace 50ct Test Strip	APX02AB0502	FDA UDI	Class II	Active
Embrace Safety Lancet	SHN02GX21.22	FDA UDI	Class II	Active
Embrace TALK 50 ct. test strip	APX03AB0303	FDA UDI	Class II	Active
EmbraceWAVE+ Blood Glucose Monitoring System Value Pack	APX04AB0402BT	FDA UDI	Class II	Active

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