KV-6 Safety Set Lid - KV-6 Safety Set Lid K10026127 - Medela AG

Duns Number:488293218

Device Description: KV-6 Safety Set Lid K10026127

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More Product Details

Catalog Number

-

Brand Name

KV-6 Safety Set Lid

Version/Model Number

080.0015

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

K150134,K150134

Product Code Details

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Device Record Status

Public Device Record Key

2688996a-728c-463f-bc2a-2f304451cebb

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

October 24, 2016

Additional Identifiers

Package DI Number

07612367045032

Quantity per Package

36

Contains DI Package

07612367045025

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