Identity
- Trade Name
- EmbraceWAVE Blood Glucose Test Strips 50 ct. FDA UDI
- Generic Name
- Glucose monitoring system IVD, home-use FDA UDI
- Device Name
- 50 test strips/vial * 1 FDA UDI
- Model / Reference
- APX04AB0404 FDA UDI
- Description
- 50 test strips/vial * 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00894030002215 FDA UDI
- 510(k) Number
- K220421 FDA UDI
- FDA Product Code
- CGA 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
Yes
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
Category: Glucose monitoring system IVD, home-use
EmbraceWAVE Blood Glucose Test Strips 50 ct. by Omnis Health, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Meter — OMNIS HEALTH, LLC
- EmbraceWAVE+ Blood Glucose Monitoring System Starter Kit — 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 |
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Manufacturer
- Manufacturer
- Omnis Health, Llc
Sources (1)
- FDA UDI 53fa2b7e-515b-4400-97c4-4e682dbee264 34 fields · synced May 30, 2026