Welch Allyn, Inc. - BT CSM NIBP Mas RRP SuerTemp - WELCH ALLYN, INC.

Duns Number:198227881

Device Description: BT CSM NIBP Mas RRP SuerTemp

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More Product Details

Catalog Number

73RT

Brand Name

Welch Allyn, Inc.

Version/Model Number

901058

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

MWI

Product Code Name

Monitor, physiological, patient (without arrhythmia detection or alarms)

Device Record Status

Public Device Record Key

da74cdc8-54b6-471e-833f-8bd7122e35ed

Public Version Date

October 06, 2021

Public Version Number

1

DI Record Publish Date

September 28, 2021

Additional Identifiers

Package DI Number

00732094336344

Quantity per Package

1

Contains DI Package

00732094335446

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