Catalog Number

-

Brand Name

NA

Version/Model Number

300K0011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2021

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

K992026

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

4decb226-2650-4f13-ab52-23b7d1a34cad

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-