Catalog Number

70030013

Brand Name

NAMIC

Version/Model Number

70030013

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

K910764,K910764

Product Code

DRS

Product Code Name

Transducer, blood-pressure, extravascular

Public Device Record Key

50dc6e9a-eab9-4c31-9e7c-a1caf03f9dfd

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Package DI Number

20193489064640

Quantity per Package

10

Contains DI Package

10193489064643

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX