Catalog Number

Z-800

Brand Name

Z-800

Version/Model Number

Z-800

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

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

K130690,K130690,K130690

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

94c7b833-845f-4e7f-b4eb-2fabcb4dbbdd

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

October 13, 2015

Package DI Number

20814371020000

Quantity per Package

4

Contains DI Package

00814371020006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box