Saliva-Check 004504

GUDID D0470045041

Saliva-Check Mutans Kit, (10) test kits wich include: 1 Mutans Test Device, 1 paraffin Gum, 1 Pipette, 1 Mixing Container, 1 bottle of Reagent #1 (2mL) and 1 bottle of Reagent #2 (4mL)

Gc America Inc.

Saliva pH IVD, kit, rapid colorimetric, clinical

• Primary Device ID: D0470045041
• NIH Device Record Key: ae5f51f6-a582-458f-9681-ebbe7f6982af
• Commercial Distribution Discontinuation: 2018-02-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Saliva-Check
• Version Model Number: 004504
• Catalog Number: 004504
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.
• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.
• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.
• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.
• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.
• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.
• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.
• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.
• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.
• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.
• Special Storage Condition, Specify: Between 0 and 0 *Store the kit in a cool dark place away from high temperatures and direct sunlight. Do not store @ 0 degrees C or below, or at high temperatures for a long time, as they may cause inaccurate results.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0470045040 [Unit of Use]
HIBCC	D0470045041 [Primary]

FDA Product Code

• EGD: WAX, DENTAL, INTRAORAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-28
• Device Publish Date: 2017-01-24

On-Brand Devices [Saliva-Check]

• 00386040012280: Saliva-Check Buffer Kit Contains: 20-in vitro pH test strips pH 5.0-8.0, saliva collection cups,
• D6589002001: Saliva-Check Buffer Kit Contains: 20-in vitro pH test strips pH 5.0-8.0, saliva collection cups,
• D0470045041: Saliva-Check Mutans Kit, (10) test kits wich include: 1 Mutans Test Device, 1 paraffin Gum, 1 P