Catalog Number

-

Brand Name

Respiguide Delivery System

Version/Model Number

7120-S

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

K130378,K130378

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

a6c4b55a-db17-4454-8985-8b620a0aced8

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

April 30, 2018

Package DI Number

10857688007275

Quantity per Package

5

Contains DI Package

00857688007278

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton