FDA UDI
In Commercial Distribution
🇺🇸 United States
Welch Allyn, Inc.
DI: 00732094318432
·
Model: 901007
·
WELCH ALLYN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Welch Allyn, Inc.
- Primary DI
- 00732094318432
- Version / Model
- 901007
- Catalog Number
- QS-6ED-CFEAB
- Company Name
- WELCH ALLYN, INC.
- Labeler DUNS
- 198227881
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-25
- Public Version
- 1
- Public Version Date
- 2023-05-03
- Public Version Status
- New
- Public Device Record Key
- 5c4da7fb-13b7-4b6b-8461-a59864a2498b
Device Description
Q-Stress Cardiac ver 6 w/ adult & ped interpretation; inc current sfw user manual CD; AM12Q Wired Acquisition Module w/ Trigger Module for TTL/analog signal output;Turnkey system w/ configured CPU & color LCD 24" mon w/ 1920 x 1080 res UK power cord; Z200+ thermal printer,( 2 packs full-grid paper A4), Q-Stress premium cart w/ base, keyboard tray, shelf, large drawer,storage pocket; IEC 10 wire, 12-lead set w/ medi-clips; Iso trans 1000 VA Med Global;Export XML Orders
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| 35447 | Cardiopulmonary stress exercise monitoring system computer | A dedicated computer with a specific software package installed intended to be used to interpret the various physiological parameters and waveforms generated during stress exercise testing of a patient while connected to a stress exercise monitoring system. These signals are provided by appropriate interfaced stress testing devices (e.g., an ergometer) using predefined pattern recognition techniques. The registered signals are compared to pre-established diagnostic criteria. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00732094318432 | GS1 |
Customer Contacts
- Phone
- +1(315)685-2834
- [email protected]