Catalog Number

Bubble PAP Valve

Brand Name

Babi.Plus

Version/Model Number

BC01-AU

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 04, 2020

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

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

f7390160-f04e-4add-a1d2-2d1569b27203

Public Version Date

May 04, 2020

Public Version Number

2

DI Record Publish Date

March 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-