Catalog Number

1137873X

Brand Name

Alice NightOne

Version/Model Number

Alice NightOne, Non-Wireless, Korea

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 2021

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

K083874

Product Code

MNR

Product Code Name

Ventilatory effort recorder

Public Device Record Key

18732f66-0ac6-4280-baeb-e21d162186b7

Public Version Date

March 05, 2021

Public Version Number

3

DI Record Publish Date

June 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-