Catalog Number

-

Brand Name

NFLOW INFANT BONNET, DARK GREY, SIZE 1

Version/Model Number

4707001

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

JAY

Product Code Name

Support, Breathing Tube

Public Device Record Key

7bbbada2-d689-4c2d-852a-c2cf66777664

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 25, 2021

Package DI Number

05030267093366

Quantity per Package

20

Contains DI Package

05030267088454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-