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EmbraceWAVE+ Blood Glucose Monitoring System Starter Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- EmbraceWAVE+ Blood Glucose Monitoring System Starter Kit FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- Starter Kit FDA UDI
- Model / Reference
- APX04AB0401BT FDA UDI
- Description
- Starter Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00894030002185 FDA UDI
- 510(k) Number
- K220421 FDA UDI
- FDA Product Code
- CGA FDA UDINBW FDA UDI
- GMDN Term
- Glucose monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glucose monitoring system IVD, home-use
EmbraceWAVE+ Blood Glucose Monitoring System Starter Kit by Omnis Health, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glucose monitoring system IVD, home-use.
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- ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
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Cleared under the same submission
K220421 also covers:
- EmbraceWAVE Blood Glucose Test Strips 100 ct. — OMNIS HEALTH, LLC
- EmbraceWAVE Blood Glucose Test Strips 25 ct. — OMNIS HEALTH, LLC
- EmbraceWAVE Blood Glucose Test Strips 50 ct. — OMNIS HEALTH, LLC
- EmbraceWAVE+ Blood Glucose Meter — OMNIS HEALTH, LLC
- EmbraceWAVE+ Blood Glucose Monitoring System Value Pack — OMNIS HEALTH, LLC
- EmbraceWAVE+ Pre-Pack (3x24) — OMNIS HEALTH, LLC
- Rite Aid Pharmacy — RITE AID CORPORATION
- Rite Aid Pharmacy — RITE AID CORPORATION
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Omnis Health, Llc
Sources (1)
- FDA UDI ef73b640-b0bc-45d4-9f4a-15cb96cb1e6e 34 fields · synced May 30, 2026