Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Cardiopulmonary stress exercise monitoring system computer FDA UDI
- Device Name
- Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clip FDA UDI
- Model / Reference
- 901144 FDA UDI
- Description
- Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clip FDA UDI
Identifiers
- Catalog Number
- QS-6ED-DEDXA FDA UDI
- Primary DI / UDI-DI
- 00732094355239 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Cardiopulmonary stress exercise monitoring system computer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary stress exercise monitoring system computer
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, 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
- Welch Allyn, Inc.
Sources (1)
- FDA UDI c3126b04-3fd4-4248-8402-b1422df5458a 35 fields · synced May 31, 2026