Identity
- Trade Name
- EnSite™ EUDAMEDFDA UDI
- Generic Name
- Transportable medical equipment stand, non-powered FDA UDI
- Device Name
- EnSite X EP System Accessories EUDAMEDRemote Monitor Stand FDA UDI
- Model / Reference
- ENSITE-RMS-01 EUDAMEDFDA UDI
- Description
- Remote Monitor Stand FDA UDI
Identifiers
- Catalog Number
- ENSITE-RMS-01 FDA UDI
- Primary DI / UDI-DI
- 05415067033598 EUDAMEDFDA UDI
- Basic UDI-DI
- 5414734DMC0038CU EUDAMED
- FDA Product Code
- DQK FDA UDI
- EMDN Code
- Z12059080 VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Transportable medical equipment stand, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Transportable medical equipment stand, non-powered
EnSite™ by St. Jude Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K202066 also covers:
- Advisor™ — ST. JUDE MEDICAL, INC.
- Advisor™ — ST. JUDE MEDICAL, INC.
- Advisor™ — ST. JUDE MEDICAL, INC.
- Advisor™ — ST. JUDE MEDICAL, INC.
- Advisor™ HD Grid, Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- Advisor™ VL, Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- Advisor™ VL, Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- Advisor™ VL, Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- Advisor™ VL, Sensor Enabled™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
K221213 also covers:
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
K223094 also covers:
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
K231415 also covers:
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
K242016 also covers:
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
- EnSite™ — ST. JUDE MEDICAL, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- St. Jude Medical, Inc.
Sources (2)
- FDA UDI 022c88cb-b6f1-429d-acdd-96611f9ecd71 37 fields · synced Oct 10, 2026
- EUDAMED a5640f9f-d55f-4cb6-a073-4cae2496a941 61 fields · synced Oct 9, 2026