Catalog Number

W18028

Brand Name

ARES 620 Respiration Effort Disposables Kit - 10 pack

Version/Model Number

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

K160499

Product Code

MNR

Product Code Name

VENTILATORY EFFORT RECORDER

Public Device Record Key

81a8504a-2873-4b7a-94c6-2d86b63d42ba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-