Catalog Number

ESN2SA

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

ESN2SA

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

-

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

-

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

b689c085-7c91-4d52-beb7-0743975e2551

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2016

Package DI Number

09420012431714

Quantity per Package

10

Contains DI Package

09420012431462

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack