Duns Number:198227881
Device Description: XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes curre XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module and RScribe with Interpretation; Turnkey system with configured CPU and color LCD 24"" monitor with 1920 x 1080 resolution; No power cord; No printer, basic laser transport cart with base and back panel; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orders (required for HL7 inte
Catalog Number
XSCRIBE-6GD-XEAAA
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)
Yes
Over the Counter (OTC)
-
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
c80d6b09-59d2-4dcd-b25c-461e880dcea0
Public Version Date
June 29, 2022
Public Version Number
3
DI Record Publish Date
August 13, 2020
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 |