Catalog Number

0T29

Brand Name

FISHER & PAYKEL HEALTHCARE

Version/Model Number

RT008

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

K953711,K953711

Product Code

BZR

Product Code Name

Mixer, Breathing Gases, Anesthesia Inhalation

Public Device Record Key

bdf3d20d-9f02-4158-aaaa-3260b32a7bba

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

September 25, 2015

Package DI Number

09420012403315

Quantity per Package

20

Contains DI Package

09420012429810

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-