Invia Motion 60 Days - Negative Pressure Wound Therapy System / 087.4000 - Medela AG

Duns Number:488293218

Device Description: Negative Pressure Wound Therapy System / 087.4000

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More Product Details

Catalog Number

-

Brand Name

Invia Motion 60 Days

Version/Model Number

Invia Motion

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 04, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Device Record Status

Public Device Record Key

1050a650-39bc-446f-b6ee-95c1f8bf6785

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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