Catalog Number

Bubble PAP Valve with 12.5 cm H O Pressure Relief Manifold

Brand Name

Babi.Plus

Version/Model Number

BC51-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

K090317,K090317

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

5be3c7e6-99af-47cf-a204-6e98c9fbf8b8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

44710810093553

Quantity per Package

12

Contains DI Package

24710810093559

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton