Catalog Number

TGDK110012

Brand Name

Thoraguard

Version/Model Number

FGS-1125

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

K181667,K181667

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

7fe52e6f-3703-4f88-af79-e4055635de2f

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

October 07, 2020

Package DI Number

10860000436417

Quantity per Package

6

Contains DI Package

00860000436410

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box