Catalog Number

-

Brand Name

Classic RT

Version/Model Number

Ultralite 15 x 1000 White

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)

-

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

52c7486b-0b30-453d-a913-7a95310e9fbe

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

March 26, 2019

Package DI Number

15404013001801

Quantity per Package

80

Contains DI Package

05404013001804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-