Catalog Number

-

Brand Name

Night Shift

Version/Model Number

NS27-1005, NS27-1006

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K140190,K140190

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

e53643df-5fb9-43b7-9fe1-a3de1a3625d3

Public Version Date

February 11, 2019

Public Version Number

1

DI Record Publish Date

January 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-