Catalog Number

1048415

Brand Name

Alice PDx

Version/Model Number

Alice PDx ExG Yoke, INTL

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

K090484

Product Code

MNR

Product Code Name

VENTILATORY EFFORT RECORDER

Public Device Record Key

8c15cd99-8583-4125-8aa8-c67088f14a22

Public Version Date

February 10, 2021

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-