Welch Allyn, Inc. - SPOT PLANNING PARENT-BP TEMP - WELCH ALLYN, INC.

Duns Number:198227881

Device Description: SPOT PLANNING PARENT-BP TEMP

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More Product Details

Catalog Number

420TB

Brand Name

Welch Allyn, Inc.

Version/Model Number

901057

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

K101680,K101680

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

f28f0ee2-cccf-4da8-a849-11a1e06e82b6

Public Version Date

September 22, 2020

Public Version Number

8

DI Record Publish Date

December 05, 2017

Additional Identifiers

Package DI Number

00732094006445

Quantity per Package

1

Contains DI Package

00732094215731

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