Catalog Number

K705

Brand Name

PMI

Version/Model Number

K705

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"

Yes

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

-

Product Code Name

-

Public Device Record Key

05d10e7a-cc62-4c8a-bcdb-88444c7aa919

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

March 14, 2018

Package DI Number

00812608021765

Quantity per Package

100

Contains DI Package

00812608021758

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box