Welch Allyn SPO2 Sensor - SPO2 Sensor for Welch Allyn Propaq LT - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: SPO2 Sensor for Welch Allyn Propaq LT

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More Product Details

Catalog Number

Not Applicable

Brand Name

Welch Allyn SPO2 Sensor

Version/Model Number

MS-WADEC4

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

K082787

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

9901ddd8-0978-4617-b1e9-d9fbe4fce98f

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

August 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90