Catalog Number

Hyperinflation System 1.0L

Brand Name

Venti.Plus

Version/Model Number

H100

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

K092687,K092687

Product Code

NHK

Product Code Name

Resuscitator,Manual,Non Self-Inflating

Public Device Record Key

450f69e2-6197-4609-b47e-e47725e6ff5c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

44710810117396

Quantity per Package

20

Contains DI Package

04710810117398

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton