Catalog Number

384837

Brand Name

Maximal Barrier Insertion Tray

Version/Model Number

384837

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

OWL

Product Code Name

Peripheral Catheter Insertion Kit

Public Device Record Key

3c620993-ee95-4f7b-940c-5f5c95ee85bd

Public Version Date

August 13, 2019

Public Version Number

1

DI Record Publish Date

August 05, 2019

Package DI Number

20886333224597

Quantity per Package

5

Contains DI Package

00886333224593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box