Catalog Number

-

Brand Name

Thopaz disposable canister 0.8l

Version/Model Number

079.0016

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

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

40907e5a-3fb3-4ca6-8fac-cab1b3e12de7

Public Version Date

January 08, 2021

Public Version Number

7

DI Record Publish Date

June 07, 2017

Package DI Number

07612367038676

Quantity per Package

6

Contains DI Package

07612367013765

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-