Catalog Number

1134120X

Brand Name

Alice NightOne

Version/Model Number

Alice NightOne, Non-Wireless, Brazil

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

949a60b8-a263-48fd-af53-be0b2fce6638

Public Version Date

March 05, 2021

Public Version Number

5

DI Record Publish Date

October 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-