Catalog Number

900SPS100

Brand Name

Fisher & Paykel Healthcare

Version/Model Number

900SPS100

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173193,K173193

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

d3f633fc-cf78-4157-91df-fbc10f1877a0

Public Version Date

May 20, 2019

Public Version Number

1

DI Record Publish Date

May 12, 2019

Package DI Number

09420012448415

Quantity per Package

10

Contains DI Package

09420012442314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX