Catalog Number

-

Brand Name

Ventlab

Version/Model Number

HS4011

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

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

NHK

Product Code Name

Resuscitator,Manual,Non Self-Inflating

Public Device Record Key

19816baf-5daf-4f5e-a96c-3a5da9bf78ab

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 20, 2016

Package DI Number

20889483110857

Quantity per Package

10

Contains DI Package

10889483110850

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box