Catalog Number

-

Brand Name

NightOwl

Version/Model Number

Mini

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

K191031,K191031

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Public Device Record Key

99c201a3-7fd4-4335-8690-422e64f9b0ac

Public Version Date

July 08, 2020

Public Version Number

1

DI Record Publish Date

June 30, 2020

Package DI Number

05430001742060

Quantity per Package

20

Contains DI Package

05430001742039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box