Catalog Number

91300012

Brand Name

NAMIC

Version/Model Number

91300012

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

K852140,K852140

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

86d1733c-c3c7-420a-93ba-89f4b5d3fddf

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Package DI Number

20193489069034

Quantity per Package

25

Contains DI Package

10193489069037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX