Catalog Number

-

Brand Name

Bunnell

Version/Model Number

902

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P850064,P850064

Product Code

LSZ

Product Code Name

Ventilator, High Frequency

Public Device Record Key

bc0e1330-75ea-473c-8a3f-0fb63b4abb47

Public Version Date

November 09, 2020

Public Version Number

4

DI Record Publish Date

July 28, 2015

Package DI Number

10616120000027

Quantity per Package

2

Contains DI Package

00616120000020

Package Discontinue Date

November 02, 2020

Package Status

Not in Commercial Distribution

Package Type

-