Identity
- Trade Name
- CardioChek FDA UDI
- Generic Name
- Multiple lipid analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- CardioChek Glucose Test FDA UDI
- Model / Reference
- 4000023 FDA UDI
- Description
- CardioChek Glucose Test FDA UDI
Identifiers
- Catalog Number
- 4000023 FDA UDI
- Primary DI / UDI-DI
- 90304040038522 FDA UDI
- 510(k) Number
- K140068 FDA UDI
- FDA Product Code
- NBW FDA UDICGA FDA UDI
- GMDN Term
- Multiple lipid analyte IVD, kit, multiple technologies 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
Yes
FDA UDI
Over-the-Counter
Yes
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: Multiple lipid analyte IVD, kit, multiple technologies
CardioChek by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple lipid analyte IVD, kit, multiple technologies.
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Cleared under the same submission
K140068 also covers:
- CardioChek — HENRY SCHEIN, INC.
- CardioChek — HENRY SCHEIN, INC.
- CardioChek — HENRY SCHEIN, INC.
- CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct — Polymer Technology Systems
- CardioChek Plus Home eGLU Self-Test Strips — Polymer Technology Systems
- CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) — Polymer Technology Systems
- CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) — Polymer Technology Systems
- PTS Panels eGLU™ Glucose Test Strips (12-ct) — Polymer Technology Systems
- PTS Panels eGLU™ Glucose Test Strips (50-ct) — Polymer Technology Systems
- PTS Panels eGLU™ Test Strips — Polymer Technology Systems
- eGLU, 15ct., CCPlus Home — Polymer Technology Systems
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
- Henry Schein, Inc.
Sources (1)
- FDA UDI 4461c5ff-53fe-4101-817a-e5919a586732 36 fields · synced May 30, 2026