Catalog Number

-

Brand Name

Disposable Overflow Protection / Virus Filter

Version/Model Number

101035264

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

-

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

K130123,K130123,K130123

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

8c8998a7-e403-47dc-8f46-a80e8024a8d8

Public Version Date

May 08, 2019

Public Version Number

1

DI Record Publish Date

April 30, 2019

Package DI Number

07612367064699

Quantity per Package

20

Contains DI Package

07612367064682

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-