Disposable bacteria / odour filter - Disposable bacteria / odour filter with Medela - Medela AG

Duns Number:488293218

Device Description: Disposable bacteria / odour filter with Medela connection

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More Product Details

Catalog Number

-

Brand Name

Disposable bacteria / odour filter

Version/Model Number

077.0575

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

K130123,K130123,K130123

Product Code Details

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Device Record Status

Public Device Record Key

feb7d25c-fdc6-4381-be65-4886af21250c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 03, 2016

Additional Identifiers

Package DI Number

07612367031622

Quantity per Package

20

Contains DI Package

07612367004183

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDELA AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 93