Catalog Number

XX01

Brand Name

N/A

Version/Model Number

XS01

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

b2fd872d-c7f0-4f85-b03d-60fd05435657

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 03, 2017

Package DI Number

10607411943901

Quantity per Package

88

Contains DI Package

00607411943904

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-