Catalog Number

1113311

Brand Name

Alice NightOne

Version/Model Number

Alice NightOne, DuraBelt, Adult Large

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

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

7f4c46a7-2a5e-4794-956b-f1c0921ceb46

Public Version Date

March 01, 2021

Public Version Number

3

DI Record Publish Date

September 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-