Welch Allyn, Inc. - BP CUFF VINYL INFANT 1-TUBE TP - WELCH ALLYN, INC.

Duns Number:198227881

Device Description: BP CUFF VINYL INFANT 1-TUBE TP

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More Product Details

Catalog Number

30506-510AUNO

Brand Name

Welch Allyn, Inc.

Version/Model Number

901044

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

Yes

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

DXQ

Product Code Name

blood pressure cuff

Device Record Status

Public Device Record Key

a4479d77-a2c5-4168-aa3b-33727a9f24c5

Public Version Date

July 01, 2022

Public Version Number

3

DI Record Publish Date

May 12, 2021

Additional Identifiers

Package DI Number

00732094344608

Quantity per Package

20

Contains DI Package

00732094344592

Package Discontinue Date

-

Package Status

In Commercial Distribution

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