Catalog Number

-

Brand Name

Thopaz disposable canister 0.3l

Version/Model Number

079.0011

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

K141553,K141553,K141553

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

8b5fe1d2-20cc-410f-89b9-3c068385c129

Public Version Date

January 08, 2021

Public Version Number

8

DI Record Publish Date

June 07, 2017

Package DI Number

07612367038652

Quantity per Package

24

Contains DI Package

07612367013758

Package Discontinue Date

July 14, 2017

Package Status

Not in Commercial Distribution

Package Type

-