Duns Number:198227881
Device Description: Welch Allyn PCH-100 Holter Office Software Kit including HR-100 Holter Recorder, 7-Lead AH Welch Allyn PCH-100 Holter Office Software Kit including HR-100 Holter Recorder, 7-Lead AHA Cable
Catalog Number
100710
Brand Name
Welch Allyn, Inc.
Version/Model Number
901052
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 10, 2022
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
MLR
Product Code Name
Sterilizer, chemical
Public Device Record Key
eca4df3c-7e5e-4af5-8745-a408b19caa1a
Public Version Date
August 11, 2022
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 |