Catalog Number

34-2317-94

Brand Name

Phadia Maintenance Solution Large

Version/Model Number

34-2317-94

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JJE

Product Code Name

ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Public Device Record Key

79525b59-b006-413e-ac75-db7c19cd6abf

Public Version Date

February 25, 2022

Public Version Number

1

DI Record Publish Date

February 17, 2022

Package DI Number

07333066022116

Quantity per Package

8

Contains DI Package

07333066022314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-