Catalog Number

5513150

Brand Name

AirGuard

Version/Model Number

5513150

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

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

1444c268-2894-45d1-afb8-b7d1dd6fa15b

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

20801741041598

Quantity per Package

12

Contains DI Package

10801741041591

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX