Catalog Number

TGCM1000

Brand Name

Thoraguard

Version/Model Number

FGN-1387

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

5ab5e631-8ba4-4cf5-8866-47800eaf15ae

Public Version Date

October 15, 2020

Public Version Number

1

DI Record Publish Date

October 07, 2020

Package DI Number

10860000436424

Quantity per Package

1

Contains DI Package

00860000436427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box