Fresenius Medical Care Holdings, Inc.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY (FKX) (6) SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE (KDJ) (4)

Premarket Exempt

Clear

Safe-Lock® - 00840861100668 Catalog Number :

Device Description : Safe-Lock® Universal Connector

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

Premier - 00840861100675 Catalog Number :

Device Description : PREMIER LUER-LOCK Transfer Set - 8 inch

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

Premier - 00840861100682 Catalog Number :

Device Description : Premier Safe-Lock® Transfer Set - 8 inch

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

stay.safe® - 00840861100699 Catalog Number :

Device Description : Multiple Tubing Segment (MTS) Set with stay.safe® PIN Connectors

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

Safe-Lock® - 00840861100705 Catalog Number :

Device Description : Safe-Lock® Catheter Adapter Co-Pack Type II

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

Liberty® - 00840861100736 Catalog Number : 050-87212

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

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

Liberty® - 00840861100743 Catalog Number : 050-87215

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

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

Liberty® - 00840861100750 Catalog Number : 050-87216

Device Description : Liberty Cycler Set, One patient connector with extended patient and drain lines

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

stay.safe® - 00840861100767 Catalog Number :

Device Description : stay.safe® Catheter Extension Set with Safe-Lock®, 12 inch

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

stay.safe® - 00840861100774 Catalog Number :

Device Description : stay.safe® to Luer-lock Adapter, 4 inch

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDJ

Prescription Use : Yes

Device Count : 1

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