Catalog Number

64000944

Brand Name

NAMIC

Version/Model Number

64000944

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

540c1806-9e6b-4f2a-8e9e-1a9e68829b6b

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Package DI Number

20193489058977

Quantity per Package

10

Contains DI Package

10193489059014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX