Catalog Number

-

Brand Name

Classic

Version/Model Number

Classic 19 Black 1830

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

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Public Device Record Key

a834dc6d-5bc1-498c-8648-be0e7bbe40cb

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

March 03, 2019

Package DI Number

15404013002228

Quantity per Package

45

Contains DI Package

05404013002221

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-