Identity
- Trade Name
- Embrace TALK control solution HI FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Embrace TALK control solution L2 FDA UDI
- Model / Reference
- APX03AB0317 FDA UDI
- Description
- Embrace TALK control solution L2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00894030002864 FDA UDI
- 510(k) Number
- K090043 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Glucose monitoring system IVD, home-use
Embrace TALK control solution HI by Omnis Health, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucose monitoring system IVD, home-use.
- Gmate® Origin Blood Glucose Monitoring System — Philosys, Inc. · Class II
- One Drop — INFORMED DATA SYSTEMS INC. · Class II
- TRUE METRIX GO — TRIVIDIA HEALTH, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC. · Class II
- LEADER — Cardinal Health 110, Inc. · Class II
- CareSens N Voice Multi — i-SENS, Inc. · Class II
Cleared under the same submission
K090043 also covers:
- Embrace Blood Glucose Monitor — OMNIS HEALTH, LLC
- Embrace TALK 100 ct. test strip — OMNIS HEALTH, LLC
- Embrace TALK 25 ct. test strip — OMNIS HEALTH, LLC
- Embrace TALK 50 ct. test strip — OMNIS HEALTH, LLC
- Embrace TALK 50 ct. test strip (Mail Order) — OMNIS HEALTH, LLC
- Embrace TALK Blood Glucose Monitor — OMNIS HEALTH, LLC
- Embrace TALK Blood Glucose Monitor (Pre-Pack 3 x 15) — OMNIS HEALTH, LLC
- Embrace TALK Blood Glucose Monitor (Pre-Pack) — OMNIS HEALTH, LLC
- Embrace TALK Control Solution L1 (LO) — OMNIS HEALTH, LLC
- HealthWise Embrace TALK Blood Glucose Monitoring System (Meter Only) — OMNIS HEALTH, LLC
- HealthWise Embrace TALK Blood Glucose Monitoring System (Starter Kit) — OMNIS HEALTH, LLC
- HealthWise Embrace TALK Blood Glucose Test Strips (50 ct.) — OMNIS HEALTH, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Omnis Health, Llc
Sources (1)
- FDA UDI f6aab374-bc34-4752-829e-192ccf706658 34 fields · synced Jun 6, 2026