Duns Number:198227881
Device Description: ProBP 2400 Digital Blood Pressure Device (Includes ProBP 2400 Device with 2,400 mAh NiMH b ProBP 2400 Digital Blood Pressure Device (Includes ProBP 2400 Device with 2,400 mAh NiMH battery (installed), (1) Adult Cuff, (1) Large Adult Cuff, (1) Power Supply with (4) Mains Blade Adapters (US, UK, EU, AU), Directions for Use CD and Calibration Certificate.)
Catalog Number
2400
Brand Name
Welch Allyn, Inc.
Version/Model Number
901096
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
DXN
Product Code Name
SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Public Device Record Key
c84b61e8-8a1c-41f1-9a21-a3772ddee14b
Public Version Date
June 21, 2022
Public Version Number
8
DI Record Publish Date
September 21, 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 |