Catalog Number

17330

Brand Name

Beckman Coulter® PK® Systems Bromelin

Version/Model Number

17330

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

BK060024,BK060024

Product Code

KSK

Product Code Name

Solution, Stabilized Enzyme

Public Device Record Key

2e22ad18-2856-4f0e-a56e-b6825681c986

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

September 18, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-