Catalog Number

1350-55

Brand Name

Medovations®

Version/Model Number

1350-55

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

GAZ

Product Code Name

Tubing, Noninvasive

Public Device Record Key

76ae4107-44ee-48ab-8ab8-a542c2524940

Public Version Date

June 08, 2021

Public Version Number

7

DI Record Publish Date

September 17, 2016

Package DI Number

M7831350551

Quantity per Package

100

Contains DI Package

M7831350550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case