Duns Number:198227881
Device Description: HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer; Report Export + DICOM bidirectional Interface
Catalog Number
HSCRIBE-6AA-BXXXB
Brand Name
Welch Allyn, Inc.
Version/Model Number
901143
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
MLO
Product Code Name
ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
Public Device Record Key
2b49e38d-0fad-453a-b05a-b6b16e098e43
Public Version Date
June 28, 2022
Public Version Number
2
DI Record Publish Date
July 01, 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 |