Catalog Number

-

Brand Name

BiTrac

Version/Model Number

313-9070

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

Yes

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

efd53d44-16e4-4d42-bf66-4f3aa3af802c

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

March 03, 2017

Package DI Number

10841470108097

Quantity per Package

10

Contains DI Package

00841470108090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-