Catalog Number

4000-U-F

Brand Name

Rescuer Manual Resuscitator

Version/Model Number

4000-U-F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K993194,K993194

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

c820c36d-8878-445b-b52c-d2a3e7b03fc5

Public Version Date

April 28, 2021

Public Version Number

1

DI Record Publish Date

April 20, 2021

Package DI Number

B0024000UF3

Quantity per Package

12

Contains DI Package

B0024000UF0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case