Sage 9001

GUDID 50618029830246

Skin Antisepsis and Oral Cleansing

SAGE PRODUCTS, LLC

Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use Oral care kit, single-use

• Primary Device ID: 50618029830246
• NIH Device Record Key: c96975c0-48ec-4104-b35f-02001f80ea70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sage
• Version Model Number: 9001
• Catalog Number: 9001
• 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
• 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 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Product Flat. Avoid excessive heat above 40C
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618029830241 [Primary]
GS1	50618029830246 [Package]; Contains: 00618029830241; Package: case [20 Units]; In Commercial Distribution

FDA Product Code

• EFW: TOOTHBRUSH, MANUAL

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: 2023-10-30
• Device Publish Date: 2023-10-22

On-Brand Devices [Sage]

• 50618029850596: Antiseptic Skin Cleansing Kit with 2% Chlorhexidine Gluconate (CHG)
• 50618029831083: Q-Care, Continue Care for the non-ventilated patient
• 50618029821527: Suction Toothbrush with Corinz
• 50618029821510: Suction Swab with Corinz
• 50618029980040: Sage AirTAP LC
• 50618029850183: Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis
• 50618029830246: Skin Antisepsis and Oral Cleansing
• 50618029791394: Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis