Catalog Number

5385

Brand Name

HUDSON RCI

Version/Model Number

IPN044945

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

K964719,K964719

Product Code

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Public Device Record Key

afa50a13-8725-4f62-b24c-d46b35a68b34

Public Version Date

August 28, 2018

Public Version Number

6

DI Record Publish Date

October 16, 2015

Package DI Number

24026704387902

Quantity per Package

10

Contains DI Package

04026704387908

Package Discontinue Date

August 27, 2018

Package Status

Not in Commercial Distribution

Package Type

Box