Catalog Number

RTG-03001

Brand Name

RespVac™

Version/Model Number

RTG-03001

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

BYY

Product Code Name

Tube, Aspirating, Flexible, Connecting

Public Device Record Key

d71f77bc-14cb-4ed4-b2f6-23d9d6eab562

Public Version Date

June 08, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

10850108006469

Quantity per Package

30

Contains DI Package

00850108006462

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton