Catalog Number

-

Brand Name

Curlin Administration Set

Version/Model Number

340-4163

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

afde0e98-dd70-4c5d-923b-637a1bc619d3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 22, 2016

Package DI Number

38148440000532

Quantity per Package

20

Contains DI Package

18148440000538

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-