Catalog Number

-

Brand Name

OLpur MD 220 - FDA

Version/Model Number

70-1220

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

K112314,K112314,K112314

Product Code

FIP

Product Code Name

Subsystem, Water Purification

Public Device Record Key

b19e7665-fcf5-499a-afc0-7dafbaf10444

Public Version Date

September 17, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20896241002057

Quantity per Package

36

Contains DI Package

10896241002050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box