Welch Allyn, Inc. - TAA REMOTE MONITORING SCALE - WELCH ALLYN, INC.

Duns Number:198227881

Device Description: TAA REMOTE MONITORING SCALE

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More Product Details

Catalog Number

T-RPM-SCALE100

Brand Name

Welch Allyn, Inc.

Version/Model Number

901077

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

-

Product Code Details

Product Code

FRI

Product Code Name

SCALE, STAND-ON, PATIENT

Device Record Status

Public Device Record Key

5a30b404-94bd-4a1a-9c73-151134a24be8

Public Version Date

March 27, 2020

Public Version Number

1

DI Record Publish Date

March 19, 2020

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