ChoiceMMed - ChoiceMMed Pulse Oximeter OxyWatch C20 - Beijing Choice Electronic Technology Co., Ltd.

Duns Number:526882823

Device Description: ChoiceMMed Pulse Oximeter OxyWatch C20

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More Product Details

Catalog Number

-

Brand Name

ChoiceMMed

Version/Model Number

OxyWatch C20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Device Record Status

Public Device Record Key

d699b0d6-a307-42ff-893b-2be0df0456c5

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

May 31, 2016

Additional Identifiers

Package DI Number

10846841032087

Quantity per Package

48

Contains DI Package

00846841032080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 259