Catalog Number

-

Brand Name

N/A

Version/Model Number

2251030

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 13, 2018

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

K121747,K121747

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

66a984bb-946a-42f3-b5b9-0749b41b420a

Public Version Date

February 07, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

05030267128259

Quantity per Package

12

Contains DI Package

05030267128242

Package Discontinue Date

February 13, 2018

Package Status

Not in Commercial Distribution

Package Type

-