Catalog Number

1047990

Brand Name

ALICE PDx

Version/Model Number

Alice PDx Sleep Diagnostic System, JP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 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

K090484

Product Code

MNR

Product Code Name

VENTILATORY EFFORT RECORDER

Public Device Record Key

9e90ce5f-a259-4cd0-85f7-3b0835c9d454

Public Version Date

March 01, 2021

Public Version Number

5

DI Record Publish Date

September 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-