Catalog Number

-

Brand Name

SPIFE 3000 w/ New Pump & Valve (110V)

Version/Model Number

1088001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K972274

Product Code

CEF

Product Code Name

ELECTROPHORETIC, PROTEIN FRACTIONATION

Public Device Record Key

b5567172-7e76-409c-ada1-b4f18b5ae229

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-