Double Pumpset - The Ardo Pumpset should be used in combination - Ardo medical AG

Duns Number:481670396

Device Description: The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating womento express and collect milk from their breast. The Pumpset can be used both as a single pumpset and as a double pumpset and is intented for single users only.

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More Product Details

Catalog Number

63.00.222

Brand Name

Double Pumpset

Version/Model Number

63.00.222

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141742,K141742

Product Code Details

Product Code

HGX

Product Code Name

Pump, Breast, Powered

Device Record Status

Public Device Record Key

b8add8bd-eb5d-4805-8b29-880c33d1b66a

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

00814079020940

Quantity per Package

8

Contains DI Package

00814079020933

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ARDO MEDICAL AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 15