Identity
- Trade Name
- EnSite™ FDA UDI
- Generic Name
- Constant-voltage transformer FDA UDI
- Device Name
- Noise Reduction Transformer, 100V FDA UDI
- Model / Reference
- H702490 FDA UDI
- Description
- Noise Reduction Transformer, 100V FDA UDI
Identifiers
- Catalog Number
- H702490 FDA UDI
- Primary DI / UDI-DI
- 05415067024909 FDA UDI
- 510(k) Number
- K141050 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Constant-voltage transformer 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: Constant-voltage transformer
EnSite™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Constant-voltage transformer.
- WALL TRANSFORMER EN 200-1 — Heine Optotechnik GmbH & Co. KG · Class II
- Isolation Transformer ‘GP’ 220-240 VAC 50/60 Hz — EB NEURO SPA · Class II
- WALL TRANSFORMER EN 200 — Heine Optotechnik GmbH & Co. KG · Class II
- Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz — EB NEURO SPA · Class II
- EnSite™ — ST. JUDE MEDICAL, INC. · Class II
- EnSite™ — ST. JUDE MEDICAL, INC. · Class II
Cleared under the same submission
K141050 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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 8ba8aadc-d9a5-4ce0-8fc8-1a606e8b3fd0 37 fields · synced Jun 6, 2026