Catalog Number

5383

Brand Name

HUDSON RCI

Version/Model Number

IPN044944

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

3071157d-bd77-49e3-9f36-5fa792488d7a

Public Version Date

August 28, 2018

Public Version Number

6

DI Record Publish Date

October 16, 2015

Package DI Number

24026704596557

Quantity per Package

10

Contains DI Package

04026704596553

Package Discontinue Date

August 27, 2018

Package Status

Not in Commercial Distribution

Package Type

Box