Catalog Number

M46445465

Brand Name

Volumat™ Line

Version/Model Number

VL PR40-11

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

K121613,K121613

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

cf47a97f-ae40-4fea-afe7-177d8b0473ba

Public Version Date

September 07, 2022

Public Version Number

3

DI Record Publish Date

May 24, 2018

Package DI Number

04250273731958

Quantity per Package

30

Contains DI Package

04250273731941

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box