Vario 18 AC - Powered suction pump026.2120 - Medela AG

Duns Number:488293218

Device Description: Powered suction pump026.2120

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

600.2607

Brand Name

Vario 18 AC

Version/Model Number

Vario 18 AC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K153663

Product Code Details

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Device Record Status

Public Device Record Key

aa655a60-87ad-4d85-9a42-3f855c4a07cd

Public Version Date

July 06, 2018

Public Version Number

3

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