PlumePort - Laparoscopic Plume Filtration Device - Buffalo Filter

Duns Number:787855907

Device Description: Laparoscopic Plume Filtration Device

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More Product Details

Catalog Number

PP010CS

Brand Name

PlumePort

Version/Model Number

ActiV

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 21, 2022

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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

-

Product Code Details

Product Code

NKC

Product Code Name

Tubing/Tubing With Filter, Insufflation, Laparoscopic

Device Record Status

Public Device Record Key

641a39f8-0680-4cad-a9e6-6a69a6ea5240

Public Version Date

April 22, 2022

Public Version Number

3

DI Record Publish Date

January 05, 2017

Additional Identifiers

Package DI Number

10815198012028

Quantity per Package

10

Contains DI Package

00815198012021

Package Discontinue Date

April 21, 2022

Package Status

Not in Commercial Distribution

Package Type

Case

"BUFFALO FILTER" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 104