Duns Number:198227881
Device Description: Welch Allyn PCH-200 Holter Expert Software Kit including HR-300 Holter Recorder, 7-Lead AH Welch Allyn PCH-200 Holter Expert Software Kit including HR-300 Holter Recorder, 7-Lead AHA Cable, Laptop Computer, Printer
Catalog Number
100713
Brand Name
Welch Allyn, Inc.
Version/Model Number
901052
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 17, 2020
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
K051730
Product Code
MLR
Product Code Name
Sterilizer, chemical
Public Device Record Key
39bbd67e-8d2d-4208-a7f2-568e6ef87b6a
Public Version Date
March 10, 2021
Public Version Number
6
DI Record Publish Date
September 17, 2016
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 |