Identity
- Trade Name
- WorkMate Claris™ FDA UDI
- Generic Name
- Cardiac catheterization monitoring system FDA UDI
- Device Name
- Cart 24 Inch FDA UDI
- Model / Reference
- H701312 FDA UDI
- Description
- Cart 24 Inch FDA UDI
Identifiers
- Catalog Number
- H701312 FDA UDI
- Primary DI / UDI-DI
- 05415067013125 FDA UDI
- FDA Product Code
- DQK FDA UDIDXJ FDA UDI
- GMDN Term
- Cardiac catheterization monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 FDA UDI870.2450 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 Claris™ 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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Cleared under the same submission
K110085 also covers:
- VantageView™ — ST. JUDE MEDICAL, INC.
- VantageView™ — ST. JUDE MEDICAL, INC.
- VantageView™ — ST. JUDE MEDICAL, INC.
- VantageView™ — ST. JUDE MEDICAL, INC.
- VantageView™ — ST. JUDE MEDICAL, INC.
- VantageView™ — ST. JUDE MEDICAL, INC.
- VantageView™ — ST. JUDE MEDICAL, INC.
- VantageView™ — ST. JUDE MEDICAL, INC.
- VantageView™ — ST. JUDE MEDICAL, INC.
- VantageView™ — ST. JUDE MEDICAL, INC.
- VantageView™ — ST. JUDE MEDICAL, INC.
- WorkMate Claris™ — ST. JUDE MEDICAL, INC.
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 7e0cce81-e603-4e04-84c4-f975d1a9bbd4 36 fields · synced May 30, 2026