Catalog Number

Pacifier Adaptor

Brand Name

Babi.Plus

Version/Model Number

PA01

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

K110471,K110471,K110471

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

7f6dc70a-448b-4f31-a5da-d7496fab5dcd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 15, 2015

Package DI Number

44710810117525

Quantity per Package

4

Contains DI Package

24710810117521

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton