Suction bag with dual filter, 2000ml - Serres Oy

Duns Number:401738638

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More Product Details

Catalog Number

-

Brand Name

Suction bag with dual filter, 2000ml

Version/Model Number

570167-5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 20, 2020

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)

-

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Device Record Status

Public Device Record Key

b92799ca-1adf-48f9-9db4-93cba5f9f5d7

Public Version Date

August 17, 2020

Public Version Number

3

DI Record Publish Date

February 05, 2018

Additional Identifiers

Package DI Number

06418685061959

Quantity per Package

6

Contains DI Package

06418685061942

Package Discontinue Date

January 20, 2020

Package Status

Not in Commercial Distribution

Package Type

Delivery box

"SERRES OY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9