Invia Liberty canister 0.3l - Canister for negative pressure wound therapy - Medela AG

Duns Number:488293218

Device Description: Canister for negative pressure wound therapy powered suction pump

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More Product Details

Catalog Number

-

Brand Name

Invia Liberty canister 0.3l

Version/Model Number

087.0012

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

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

K142626,K142626

Product Code Details

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Device Record Status

Public Device Record Key

e1621d04-3ed2-442e-b37d-fdb1f5fceac2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 20, 2017

Additional Identifiers

Package DI Number

07612367038799

Quantity per Package

10

Contains DI Package

07612367015455

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