Catalog Number

-

Brand Name

SINGLE LEAD HIGH VOLUME PUMP CHAMBER SET

Version/Model Number

17789HP3M-10PK

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JTB

Product Code Name

Device, Media Dispensing/Stacking

Public Device Record Key

a8d71d5e-e795-4a38-b08c-7e2162c345ce

Public Version Date

September 01, 2022

Public Version Number

1

DI Record Publish Date

August 24, 2022

Package DI Number

10810080610542

Quantity per Package

10

Contains DI Package

00810080610545

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case