Catalog Number

N48937

Brand Name

Halyard

Version/Model Number

46790

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

c1a5f950-82bb-4a37-95ed-aca1b536c63c

Public Version Date

December 13, 2021

Public Version Number

5

DI Record Publish Date

December 21, 2017

Package DI Number

30680651467905

Quantity per Package

25

Contains DI Package

10680651467901

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS