Catalog Number

WM1603

Brand Name

ARES 610 Unicorder

Version/Model Number

610

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

K110705,K111194,K112514

Product Code

MNR

Product Code Name

VENTILATORY EFFORT RECORDER

Public Device Record Key

2dc4c52e-0ad5-49ff-87ca-2ac63de5636a

Public Version Date

March 21, 2022

Public Version Number

5

DI Record Publish Date

May 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-