Liberty® - Liberty® Cycler Set with Single stay.safe® PIN - Fresenius Medical Care Holdings, Inc.

Duns Number:958291411

Device Description: Liberty® Cycler Set with Single stay.safe® PIN Connector

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More Product Details

Catalog Number

050-87215

Brand Name

Liberty®

Version/Model Number

050-87215

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"

Yes

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

K043363,K173718,K043363,K173718

Product Code Details

Product Code

FKX

Product Code Name

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Record Status

Public Device Record Key

76f733e9-f08d-4965-bbb9-b8bc2cd73725

Public Version Date

March 01, 2021

Public Version Number

4

DI Record Publish Date

October 02, 2015

Additional Identifiers

Package DI Number

10840861100740

Quantity per Package

10

Contains DI Package

00840861100743

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