Catalog Number

565010

Brand Name

QDC Adapter Kit

Version/Model Number

NOX-QDCA1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 27, 2017

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

K151361,K151361

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

4e9bae24-271d-4934-9993-559a2a873a3a

Public Version Date

October 26, 2020

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

-