Liberty® - Liberty® Drain Set - Fresenius Medical Care Holdings, Inc.

Duns Number:958291411

Device Description: Liberty® Drain Set

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More Product Details

Catalog Number

026-20226

Brand Name

Liberty®

Version/Model Number

026-20226

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

K811986,K811986

Product Code Details

Product Code

FKX

Product Code Name

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Record Status

Public Device Record Key

3dcfef07-53b3-4a44-9b2e-e3f47afbdcef

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 02, 2015

Additional Identifiers

Package DI Number

10840861100627

Quantity per Package

10

Contains DI Package

00840861100620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"FRESENIUS MEDICAL CARE HOLDINGS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 65