Q-Care 6984

GUDID 57613327680749

Sage Q-Care Rx Oral Cleansing and Suctioning System

SAGE PRODUCTS, LLC

Oral care kit, single-use

• Primary Device ID: 57613327680749
• NIH Device Record Key: c6f07aad-c07a-4634-ac15-5570e3b2732d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q-Care
• Version Model Number: 6984
• Catalog Number: 6984
• Company DUNS: 054326178
• Company Name: SAGE PRODUCTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com
• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com
• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com
• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com
• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com
• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com
• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com
• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com
• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com
• Phone: +1(800)323-2220
• Email: customer-service-spcl@sageproducts.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursion permitted to 15C to 30C. See USP Controlled Room Temperature
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327680744 [Primary]
GS1	57613327680749 [Package]; Contains: 07613327680744; Package: case [20 Units]; In Commercial Distribution

FDA Product Code

• NSB: Patient personal hygiene kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-11
• Device Publish Date: 2025-12-03

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• 50618029841341: Q-Care, Oropharyngeal Suction Catheter with Thumb Port
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• 50618029841204: Q-Care, Q2 Oral Cleansing & Suctioning System
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• 50618029831045: Q-Care, Q4, Oral Cleansing & Suctioning System
• 50618029831038: Q-Care, Q4, Oral Cleansing & Suctioning System
• 50618029831021: Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral
• 50618029830949: Q care, Oral Cleansing & Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral R
• 50618029830772: Q-Care, Oral Cleansing & Suctioning System
• 50618029830765: Q Care Rx, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rins
• 50618029830758: Q Care Rx, Oral Cleansing & suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rins
• 50618029830741: Q-Care, Oral Cleansing & Suctioning System
• 50618029830710: Q Care, Q4 Oral Cleansing & Suctioning System, Suction Toothbrush Compatible with Chlorhexidine
• 50618029830413: Q-Care, Continue Care for the non-ventilated patient- 4 Steps
• 50618029830406: Q-Care, Continue Care for the non-ventilated patient- 3 Steps
• 50618029830383: Q-Care, Petite Size Oral Cleansing & Suctioning System
• 50618029830352: Q-Care, Q4 Oral Cleansing & Suctioning System
• 50618029830338: Q Care, Q4 Oral Cleansing & Suctioning System, Suction Toothbrush Compatible with Chlorhexidine
• 50618029830321: Q Care, Q2 Oral Cleansing & Suctioning System, Suction Toothbrush Compatible with Chlorhexidine
• 50618029830314: Q-Care, Q2, Oral Cleansing & Suctioning System
• 50618029830277: Q-Care, Q4, Oral Cleansing & Suctioning System
• 50618029830178: Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral
• 50618029830161: Q Care Rx, Q2, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral
• 50618029830086: Q Care Rx, Q4, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral
• 50618029821091: Suction Toothbrush with Antiseptic Oral Rinse
• 50618029800935: Q-Care Covered Yankauer and Suction Handle
• 50618029800928: Suction Toothbrush with Perox-A-Mint Solution
• 50618029800911: Suction Catheter
• 50618029800904: Q-Care Covered Yankauer, Suction Handle, and Y- Connector
• 50618029800874: Suction Swabs with Perox-A-Mint Solution
• 50618029841471: Q-Care Covered Yankauer, Suction Handle, and Y- Connector
• 50618029830970: Q Care, Q4 Oral Cleansing & Suctioning System, Petite, 0.12% Chlorhexidine Gluconate Oral Rinse
• 50618029830987: SALESMAN SAMPLES, Q-Care, Petite Size, Oral Cleansing & Suctioning System with 0.12 Chlorhexidin
• 50618029830819: Q-Care Rx, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rins
• 50618029830802: Q-Care Rx, Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rins
• 57613327680756: Sage Q-Care Oral Cleansing and Suctioning System
• 57613327680749: Sage Q-Care Rx Oral Cleansing and Suctioning System
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