Catalog Number

nCPAP Nasal Prong Size 3

Brand Name

Babi.Plus

Version/Model Number

B023

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAT

Product Code Name

Cannula, Nasal, Oxygen

Public Device Record Key

d46f929d-db4e-43b4-8455-86d05ed59c5a

Public Version Date

March 22, 2022

Public Version Number

3

DI Record Publish Date

October 15, 2015

Package DI Number

44710810119734

Quantity per Package

4

Contains DI Package

24710810119730

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton