Catalog Number

15043-000-0005

Brand Name

Splitter- US

Version/Model Number

15043-000-0005

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

-

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

K123049,K123049,K123049,K123049

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Public Device Record Key

120a97ff-6a06-408f-a0ba-fa6c6c5d5f70

Public Version Date

March 26, 2019

Public Version Number

3

DI Record Publish Date

May 24, 2018

Package DI Number

27290109150271

Quantity per Package

60

Contains DI Package

17290109150274

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cardboard box