Catalog Number

51019

Brand Name

HUDSON RCI

Version/Model Number

IPN039370

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

-

Product Code

BTM

Product Code Name

Ventilator, emergency, manual (resuscitator)

Public Device Record Key

ffbcbafc-7261-47ec-be00-086cd36a0d84

Public Version Date

January 20, 2021

Public Version Number

4

DI Record Publish Date

October 04, 2019

Package DI Number

34026704662310

Quantity per Package

200

Contains DI Package

24026704662313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case