Catalog Number

561211

Brand Name

QDC-PRO Sensor Unit

Version/Model Number

NOX-QDCP1ETL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 2022

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K124062

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

10f51b1a-ec9d-4acd-af8c-5a15c9effeb9

Public Version Date

April 14, 2022

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-