Catalog Number

419102650

Brand Name

ACTion Block Pump, 650ml, 5-15 ml/hr

Version/Model Number

419102650

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

K072053,K072053

Product Code

MEB

Product Code Name

PUMP, INFUSION, ELASTOMERIC

Public Device Record Key

0b1996e3-bbf3-46ff-9df5-1b0f6d43da1f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

05707480120789

Quantity per Package

4

Contains DI Package

05707480120772

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-