Catalog Number

1090830

Brand Name

CoughAssist

Version/Model Number

CoughAssist 70 Series Circuit, Infant, 6ft

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"

Yes

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

K121955

Product Code

NHJ

Product Code Name

DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Public Device Record Key

952b9ff2-de80-43fe-b2de-645b456ab01c

Public Version Date

June 22, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-