Identity
- Trade Name
- Tapsystem FDA UDI
- Generic Name
- Temporary cardiac pacing/stimulation connection cable, reusable FDA UDI
- Device Name
- A cable used to connect a patient to a Model 2A pulse generator system for the treatment of cardiac dysrhythmias. FDA UDI
- Model / Reference
- 2A Patient Cable FDA UDI
- Description
- A cable used to connect a patient to a Model 2A pulse generator system for the treatment of cardiac dysrhythmias. FDA UDI
Identifiers
- Catalog Number
- 2010 FDA UDI
- Primary DI / UDI-DI
- 00856233005073 FDA UDI
- PMA Number
- P840002 FDA UDI
- FDA Product Code
- LPA FDA UDI
- GMDN Term
- Temporary cardiac pacing/stimulation connection cable, reusable FDA UDI
Classification
- Device Class
- Class III 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: Temporary cardiac pacing/stimulation connection cable, reusable
Tapsystem by Cardio Command — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temporary cardiac pacing/stimulation connection cable, reusable.
- Model 7A — Cardio Command · Class III
Cleared under the same submission
P840002 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Cardio Command
Sources (1)
- FDA UDI 1956b9de-05bb-4a4e-85be-3b73141bbe92 36 fields · synced Jun 1, 2026