Catalog Number

-

Brand Name

NAMIC

Version/Model Number

91300035

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

K852140,K852140

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

130cae05-44a5-4ddc-b669-beb6f32ae11d

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

H965913000351

Quantity per Package

25

Contains DI Package

H965913000350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX