Catalog Number

WM-1004

Brand Name

ARES Secure Sleep Study Disposable Kit - 10 pack

Version/Model Number

610/620

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

Yes

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

5a83211a-ae92-4110-bec0-007ddac52cda

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-