Catalog Number

-

Brand Name

Antmed

Version/Model Number

PT153208

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

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

K091408,K091408

Product Code

DRS

Product Code Name

Transducer, Blood-Pressure, Extravascular

Public Device Record Key

66ce6efc-86e3-4b28-9ffa-6fbf6f66ec2f

Public Version Date

October 31, 2018

Public Version Number

5

DI Record Publish Date

August 25, 2017

Package DI Number

06945764415162

Quantity per Package

10

Contains DI Package

06945764415155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-