Catalog Number

-

Brand Name

NA

Version/Model Number

612K0037-50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2020

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

K992026,K992026

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

51842648-f0bf-4f0f-885f-ef3344eaf2b0

Public Version Date

November 09, 2021

Public Version Number

4

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-