Catalog Number

ME2069

Brand Name

MaxGuard

Version/Model Number

ME2069

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

f4ed9040-5c1a-4bcc-b48c-ab40c65afc92

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

20885403424295

Quantity per Package

12

Contains DI Package

50885403424296

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box