Catalog Number

-

Brand Name

FISHER & PAYKEL HEALTHCARE

Version/Model Number

900MR190

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

K953949,K953949

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Public Device Record Key

28903720-166c-4ea5-8956-290d4a2499fc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 25, 2015

Package DI Number

09420012401465

Quantity per Package

30

Contains DI Package

09420012429780

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-