Catalog Number

-

Brand Name

BiTrac SE Select

Version/Model Number

313-9601

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

K023683,K023683

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

ddf4142a-c799-43b7-9c29-0182ec8bddc7

Public Version Date

November 19, 2018

Public Version Number

1

DI Record Publish Date

October 19, 2018

Package DI Number

10841470111684

Quantity per Package

10

Contains DI Package

00841470111687

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-