Welch Allyn, Inc. - ProBP 2400 Digital Blood Pressure Device - WELCH ALLYN, INC.

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.)

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More Product Details

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

Product Characteristics

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 Details

Product Code

DXN

Product Code Name

SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELCH ALLYN, INC." Characteristics
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