Catalog Number

5008203

Brand Name

Diasafe

Version/Model Number

5008201

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

K944767,K944767

Product Code

FIP

Product Code Name

SUBSYSTEM, WATER PURIFICATION

Public Device Record Key

72fc770e-4a9f-4dec-8c14-4ba17a1c761d

Public Version Date

March 30, 2020

Public Version Number

3

DI Record Publish Date

October 23, 2015

Package DI Number

04039361001391

Quantity per Package

10

Contains DI Package

04039361001384

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box