SAGE PRODUCTS, LLC

Address:3909 3 Oaks Rd,CARY,IL,60013,US

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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

BEDDING, DISPOSABLE, MEDICAL (KME) (2) CATHETER AND TIP, SUCTION (JOL) (2) DEVICE, TRANSFER, PATIENT, MANUAL (FMR) (2) Collector, urine, powered, non indwelling catheter (NZU) (1) SUPPORT, PATIENT POSITION (CCX) (1) LIFT, PATIENT, NON-AC-POWERED (FSA) (1) Patient personal hygiene kit (NSB) (1) Protector, skin pressure (FMP) (1) COLLECTOR, OSTOMY (EXB) (1)

Premarket Exempt

Yes

Clear

Prevalon - 00618029980014 Catalog Number : 700-093

Device Description : TrendeMATS Mobile Air Transfer System for Trendelenburg Position

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : FMR, KME, CCX

Prescription Use : No

Device Count : 1

Self Oral Care Kit - 00618029980021 Catalog Number : 700-083

Device Description : Patient Personal Hygiene Kit

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL, NSB

Prescription Use : No

Device Count : 1

Self Oral Care Kit - 00618029980038 Catalog Number : 700-114

Device Description : Patient Personal Hygiene Kit

Device Class : 2

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : No

Device Count : 1

Sage - 00618029980045 Catalog Number : 700-115

Device Description : Sage AirTAP LC

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : FMP, KME, FSA, FMR

Prescription Use : No

Device Count : 1

Sage Fecal Management System - 00618029980052 Catalog Number : 700-118

Device Description : Sage Fecal Management System

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : EXB

Prescription Use : No

Device Count : 1

Streamline External Urine Management device - 00618029980069 Catalog Number : 700-120 SMS

Device Description : Streamline External Urine Management device

Device Class : 1

Duns Number: 054326178

Premarket Exempt : Yes

Product Code : NZU

Prescription Use : No

Device Count : 1

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