Catalog Number

0W90

Brand Name

FISHER & PAYKEL HEALTHCARE

Version/Model Number

RD1360-10

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

K892885,K892885

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Public Device Record Key

5d164be0-b8b1-452a-97d5-3b8305ed413e

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

September 25, 2015

Package DI Number

09420012424242

Quantity per Package

10

Contains DI Package

09420012430076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-