Identity
- Trade Name
- Tapscope FDA UDI
- Generic Name
- Electronic oesophageal stethoscope, single-use FDA UDI
- Device Name
- 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a male temperature connector, (single unit package). FDA UDI
- Model / Reference
- 550, single pack FDA UDI
- Description
- 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a male temperature connector, (single unit package). FDA UDI
Identifiers
- Catalog Number
- 200 FDA UDI
- Primary DI / UDI-DI
- 00856233005004 FDA UDI
- PMA Number
- P860008 FDA UDI
- FDA Product Code
- BZT FDA UDI
- GMDN Term
- Electronic oesophageal stethoscope, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 18 French FDA UDI
Category: Electronic oesophageal stethoscope, single-use
Tapscope by Cardio Command — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electronic oesophageal stethoscope, single-use.
- Truer Medical, Inc. — TRUER MEDICAL, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- Truer Medical, Inc. — TRUER MEDICAL, INC. · Class II
- LIFESOUND — NOVAMED-USA · Class II
- NOVATEMP — NOVAMED-USA · Class II
- Mon-a-Therm — Covidien LP · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Cleared under the same submission
P860008 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardio Command
Sources (1)
- FDA UDI 6825fb48-8986-4da4-886b-b022399fe2c0 37 fields · synced May 31, 2026