Catalog Number

EH050-18

Brand Name

Temena

Version/Model Number

EH050-18

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CAZ

Product Code Name

Anesthesia Conduction Kit

Public Device Record Key

a479a346-3303-4c12-b639-24be66b35766

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

December 12, 2017

Package DI Number

03700339705245

Quantity per Package

3

Contains DI Package

03700339715244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box