MOX4 - MOX4, Medical Oxygen Sensor - CITY TECHNOLOGY LIMITED

Duns Number:227246220

Device Description: MOX4, Medical Oxygen Sensor

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More Product Details

Catalog Number

-

Brand Name

MOX4

Version/Model Number

AA829-M20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

CCL

Product Code Name

Analyzer, Gas, Oxygen, Gaseous-Phase

Device Record Status

Public Device Record Key

d0558712-1988-401a-ac5f-6c167641276c

Public Version Date

December 30, 2019

Public Version Number

4

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CITY TECHNOLOGY LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14