Catalog Number

NC020-20

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

NC020-20

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

K971695,K971695

Product Code

FMT

Product Code Name

Warmer, Infant Radiant

Public Device Record Key

797f3e80-1dba-49ed-a1b8-4cc357b49db6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 08, 2016

Package DI Number

09420012418845

Quantity per Package

20

Contains DI Package

09420012433145

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack