Catalog Number

0T30

Brand Name

FISHER & PAYKEL HEALTHCARE

Version/Model Number

RT043S

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

K060044,K060044

Product Code

MNT

Product Code Name

Ventilator, Continuous, Minimal Ventilatory Support,Facility Use

Public Device Record Key

e37a44fc-2d29-4be3-8cd9-3d42751b4f1e

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

September 25, 2015

Package DI Number

09420012426833

Quantity per Package

10

Contains DI Package

09420012429902

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-