Identity
- Trade Name
- WorkMate™ Unity™ FDA UDI
- Generic Name
- Cardiac catheterization monitoring system FDA UDI
- Device Name
- Software Upgrade Site License FDA UDI
- Model / Reference
- H800021 FDA UDI
- Description
- Software Upgrade Site License FDA UDI
Identifiers
- Catalog Number
- H800021 FDA UDI
- Primary DI / UDI-DI
- 05415067047199 FDA UDI
- 510(k) Number
- K210392 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Cardiac catheterization monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac catheterization monitoring system
WorkMate™ Unity™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiac catheterization monitoring system.
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- EpiAccess Control Unit — Epiep, Inc. · Class II
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- ICU Medical — ICU MEDICAL, INC. · Class II
- Mac-Lab — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. · Class II
Cleared under the same submission
K210392 also covers:
- EP-4™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
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
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 2bcd2258-980e-435f-87df-362fe4d124e4 36 fields · synced May 30, 2026