Catalog Number

01-001025

Brand Name

D3

Version/Model Number

01-001025

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

-

Product Code

KIP

Product Code Name

FORMULATIONS, BALANCED SALT SOLUTIONS

Public Device Record Key

b8493835-a14a-44c6-a7a8-d46b68f407ee

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 31, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-