Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1419181

FEI Number

1419181

Entity Name

SAGE PRODUCTS LLC

City/State/Country

CARY, IL, US

Establishment Address

3909 3 Oaks Rd, CARY, IL 60013, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

SAGE PRODUCTS LLC (Owner Number: 9914017)

Owner / Operator Contact Address

3909 THREE OAKS RD., --, Cary, IL 60013, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Q-Care with Thumb Port Toothette Oral Care Q-Care with Suction Handle Continue Care Systems Q-Care Rx Independent Care System Sage Self Oral Care Petite Short Term Swab System Ultra-soft Toothbrush and Applicator Swab Sage AirTAP® LC Lift Compatible Patient Repositioning System Sage AirTAP® LC Lift Compatible Glide Sheet Sage TAP LC - Lift Compatible Patient Repositioning System Sage TAP LC - Lift Compatible Glide Sheet Sage Multi-Position MATS Mobile Air Transfer System Sage Multi-Position Mats Mobile Air Transfer System Secure Foam Body Strap Sage Multi-Position Mats Mobile Air Transfer System Arm Wraps Sage Multi Position MATS 2 without SecureFoam Arm Wraps Sage SecureFoam Arm Wraps Sage Multi-Position MATS 2 Mobile Air Transfer System Sage SecureFoam Body Strap Sage Multi-Position MATS 2 Mobile Air Transfer System Reprocessed Prevalon AirTAP Patient Repositioning System Prevalon Turn and Position System 1 (TAP 1) Prevalon Turn and Position System 2 (TAP 2) Prevalon AirTAP Patient Repositioning System Prevalon AirTAP XXL Patient Repositioning System Glide Sheet Sage Basic Positioning Sheet Prevalon AirTAP XXL Patient Repositioning System Sage HalfMATS Mobile Air Transfer System Prevalon Mobile Air Transfer System Reprocessed Prevalon Mobile Air Transfer System Prevalon TAP XXL Low Friction Glide Sheet Prevalon TAP 1 Low Friction Glide Sheet Sage AirTAP® LC Lift Compatible Patient Repositioning System Prevalon Mobile Air Transfer Mat Prevalon TAP XXL Turn and Position System Prevalon Air Pump Prevalon TAP XL Low Friction Glide Sheet Prevalon TAP XL Turn and Position System Prevalon TAP 2 Low Friction Glide Sheet Sage HalfMATS Mobile Air Transfer HalfMATS Prevalon AirTAP Glide Sheet Reprocessed Prevalon Mobile Air Transfer Mat Prevalon Booster Pump Sage AirTAP LC Lift Compatible Glide Sheet Sage Multi-Position MATS Mobile Air Transfer MAT Sage 25' inflation hose Sage TAP LC - Lift Compatible Patient Repositioning System Sage TAP LC - Lift Compatible Glide Sheet Sage Multi Position MATS 2 without SecureFoam Arm Wraps Continue Care Applicator Swab Toothette Oral Care Applicator Swab Q-Care Applicator Swab PrimoFit Flow External Urine Management for the Male Anatomy Sage PrimaFIT External Urine Management System for the Female Anatomy Sage PrimoFit+ External Urine Management for the Male Anatomy Disposable Polyester Dry Cloths M2 Microclimate Body Pad M2 Microclimate Body Pad XL M2 Microclimate Body Pad XXL Sage Multi-Position Mats Mobile Air Transfer System Draw Sheet Microclimate Management Pad Bite Block Prevalon Seated Positioning System (SPS) Prevalon Seated Positioning Cushion with Fastener Strips Sage Sage Self Oral Care Q-Care Suction Catheter Continue Care Suction Oral Swab Toothette Suction Handle and Covered Yankauer Toothette Suction Oral Swab Continue Care Covered Yankauer Continue Care Suction Toothbrush Q-Care Suction Oral Swab Toothette Suction Catheter Q-Care Suction Toothbrush Toothette Suction Toothbrush Q-Care Covered Yankauer Sage Self Oral Care Suction Toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2008-11-03
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	2019-06-18
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2018-08-30
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2011-02-18
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2010-12-06
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2017-02-13
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2018-11-12
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2013-02-05
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2016-04-15
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2013-02-05
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2000-07-07
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	1995-06-28

Official Correspondent

Steven Merrill

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SAGE PRODUCTS LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015237508	ADVANCED MEDICAL BALLOONS GMBH	Waghaeusel Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1419181. Last updated year: 2026. Please use registration number 1419181 when referencing this establishment in official correspondence.