FDA UDI
In Commercial Distribution
🇺🇸 United States
Welch Allyn, Inc.
DI: 00732094358292
·
Model: 901144
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Welch Allyn, Inc.
- Primary DI
- 00732094358292
- Version / Model
- 901144
- Catalog Number
- QS-6FA-AEDAA
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-11
- Public Version
- 1
- Public Version Date
- 2025-07-21
- Public Version Status
- New
- Public Device Record Key
- aac61de7-1d53-4bbb-9e88-202816b6d5cb
Device Description
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and Web Direct Card for IFUs; WAM Wireless Acquisition Module; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24" monitor with 1920 x 1080 resolution; US/Canada 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- clips for WAM ONL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DPS | Electrocardiograph | Cardiovascular | 870.2340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36146 | Cardiopulmonary stress exercise monitoring system | An assembly of devices intended to noninvasively assess the cardiopulmonary response to exercise or measure of energy expenditure using indirect calorimetry. Breath by breath measurements of flow, oxygen (O2) uptake, and carbon dioxide (CO2) production are performed by O2 and CO2 analysers during exercise, along with the measurement of vital parameters. A mask, mouthpiece, or hood is attached to tubing and connected from the patient to the gas analysers while exercise is being performed using a particular device (e.g., an ergometer). The system typically monitors functions [e.g., provides continuous electrocardiogram (ECG)], provides control of the workload, and displays and prints results. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00732094358292 | GS1 |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]