Catalog Number

-

Brand Name

NAMIC

Version/Model Number

70030021

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"

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

K910764,K910764

Product Code

DRS

Product Code Name

TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Public Device Record Key

4b78336e-1d78-426f-b92a-63ec471b5512

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

H965700300211

Quantity per Package

10

Contains DI Package

H965700300210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX