Welch Allyn, Inc. - SunTech Tango BP Monitor large adult cuff with - WELCH ALLYN, INC.

Duns Number:198227881

Device Description: SunTech Tango BP Monitor large adult cuff with microphone, 32-44 cm, for use with Tango+

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More Product Details

Catalog Number

042061-009

Brand Name

Welch Allyn, Inc.

Version/Model Number

901146

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122401

Product Code Details

Product Code

DXN

Product Code Name

System, measurement, blood-pressure, non-invasive

Device Record Status

Public Device Record Key

249cf60d-ffd8-47fd-bc68-b9eb0374450f

Public Version Date

May 13, 2021

Public Version Number

1

DI Record Publish Date

May 05, 2021

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