Catalog Number

-

Brand Name

SINGLE USE ADULT 1600ML RESUSCITATOR W/O POP-OFF, L TYPE ADAPTER, HAND STRAP

Version/Model Number

RE-24431

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"

-

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

K021442

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

2f008d6d-bc27-43b6-a30c-e38e2a5f2529

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-