Catalog Number

-

Brand Name

Suction bag with solidifier 2.5l

Version/Model Number

077.0087

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

K130123,K130123,K130123

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

2f76311f-4bd9-4124-bda7-03433ddd350c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 20, 2016

Package DI Number

07612367031738

Quantity per Package

3

Contains DI Package

07612367031356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-