Catalog Number

1114801X

Brand Name

Alice NightOne

Version/Model Number

Alice NightOne, Wireless, Global

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code

MNR

Product Code Name

VENTILATORY EFFORT RECORDER

Public Device Record Key

ce6066d7-f519-4a27-ab3c-b5c509d60cf6

Public Version Date

March 04, 2021

Public Version Number

3

DI Record Publish Date

October 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-