Catalog Number

-

Brand Name

Tenacore

Version/Model Number

1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081335,K081335

Product Code

BZR

Product Code Name

Mixer, Breathing Gases, Anesthesia Inhalation

Public Device Record Key

2f3498c7-563f-4910-902c-28ff761503ee

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

10861269000210

Quantity per Package

1

Contains DI Package

00861269000213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-