Catalog Number

ME1048

Brand Name

MaxGuard

Version/Model Number

ME1048

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

36c1acaf-8abd-4d2c-89f8-0aefd4345382

Public Version Date

January 13, 2022

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

50885403236004

Quantity per Package

50

Contains DI Package

10885403236006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack