Catalog Number

MC0020M-CPNB

Brand Name

ARROW

Version/Model Number

IPN048017

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

K090300,K090300

Product Code

MEB

Product Code Name

PUMP, INFUSION, ELASTOMERIC

Public Device Record Key

6402186d-cec9-49d9-b9d2-e0cd103b3690

Public Version Date

February 21, 2022

Public Version Number

4

DI Record Publish Date

March 04, 2019

Package DI Number

24026704612295

Quantity per Package

5

Contains DI Package

14026704612298

Package Discontinue Date

February 18, 2022

Package Status

Not in Commercial Distribution

Package Type

Box