Catalog Number

12.5 cmH O Pressure Relief Manifold

Brand Name

Babi.Plus

Version/Model Number

BC23-AU

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

-

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

K110383,K110383

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

54c943cd-f318-4d23-855c-9374abc5961e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

44710810093560

Quantity per Package

12

Contains DI Package

04710810093562

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton