Duns Number:198227881
Device Description: Welch Allyn Home Blood Pressure Monitor (1500 Series) with D-Ring Standard Wide Cuff (22-4 Welch Allyn Home Blood Pressure Monitor (1500 Series) with D-Ring Standard Wide Cuff (22-42cm), 4 Alkaline AA batteries. Home Blood Pressure Monitor may be used standalone, or in conjunction with the Welch Allyn Home Hypertension Program Clinical Portal and Patient Application. May also be integrated into third party Remote Patient Monitoring (RPM) solutions.
Catalog Number
RPM-BP100
Brand Name
Welch Allyn, Inc.
Version/Model Number
901042
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
DXN
Product Code Name
System, measurement, blood-pressure, non-invasive
Public Device Record Key
460dd09c-7b9e-4dc9-b8ca-cb2c2c5b9900
Public Version Date
August 28, 2020
Public Version Number
1
DI Record Publish Date
August 20, 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 |