Duns Number:198227881
Device Description: XScribe Cardiac Stress – ver 6 w/ adult and ped interp; w/ current sfw CD and User Manual XScribe Cardiac Stress – ver 6 w/ adult and ped interp; w/ current sfw CD and User Manual CD; WAM Wireless Acquisition Module w/ Trigger Module for TTL/analog signal output; Turnkey system w/ config CPU and ELO brand capacitive color touchscreen 24" monitor w/ 1920 x 1080 res; UK pwr cord; Z200+ thermal printer(w/ starter pk of full-grid paper), basic transport cart/ base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set w/ medi-clips; Isolation transformer 1000 VA Med Global
Catalog Number
XSCRIBE-6AB-CDBAA
Brand Name
Welch Allyn, Inc.
Version/Model Number
901144
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
592a09ec-22aa-4cb8-b841-c1f4738f4857
Public Version Date
June 27, 2022
Public Version Number
2
DI Record Publish Date
May 20, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |