Catalog Number

Bubble PAP Valve

Brand Name

Babi.Plus

Version/Model Number

BC01-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

2d520d07-56ab-40df-adf0-8db2e7511aaf

Public Version Date

May 04, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

44710810105263

Quantity per Package

12

Contains DI Package

04710810105265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton