Identity
- Trade Name
- Pacel™ FDA UDI
- Generic Name
- Temporary cardiac pacing catheter FDA UDI
- Device Name
- Bipolar Pacing Catheter FDA UDI
- Model / Reference
- 401776 FDA UDI
- Description
- Bipolar Pacing Catheter FDA UDI
Identifiers
- Catalog Number
- 401776 FDA UDI
- Primary DI / UDI-DI
- 05414734001236 FDA UDI
- FDA Product Code
- LDF FDA UDI
- GMDN Term
- Temporary cardiac pacing catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 6 French FDA UDI
Category: Temporary cardiac pacing catheter
Pacel™ by St. Jude Medical Cardiovascular Division — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary cardiac pacing catheter.
- GOETZ™ Temporary Pacing Electrode Catheter — C. R. Bard, Inc. · Class II
- NBIH™ Temporary Pacing Electrode Catheter — C. R. Bard, Inc. · Class II
- NBIH™ Temporary Pacing Electrode Catheter — C. R. Bard, Inc. · Class II
- NBIH™ Temporary Pacing Electrode Catheter — C. R. Bard, Inc. · Class II
- NBIH™ Temporary Pacing Electrode Catheter — C. R. Bard, Inc. · Class II
- GOETZ™ Temporary Pacing Electrode Catheter — C. R. Bard, Inc. · Class II
- NBIH™ Temporary Pacing Electrode Catheter — C. R. Bard, Inc. · Class II
- GOETZ™ Temporary Pacing Electrode Catheter — C. R. Bard, Inc. · Class II
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 Cardiovascular Division
Sources (1)
- FDA UDI fc4b1968-6f88-4e04-8761-dd588ea65edf 37 fields · synced May 30, 2026