Saliva-Check 900200

GUDID D6589002001

Saliva-Check Buffer Kit Contains: 20-in vitro pH test strips pH 5.0-8.0, saliva collection cups, wax for saliva stimulation, saliva dispensing pipettes, buffer test strips

Gc America Inc.

Saliva pH IVD, kit, rapid colorimetric, clinical

• Primary Device ID: D6589002001
• NIH Device Record Key: d7af05b8-d855-49f6-ab77-e6a8dde89251
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saliva-Check
• Version Model Number: 900200
• Catalog Number: 900200
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 20
• 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

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6589002000 [Unit of Use]
HIBCC	D6589002001 [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: 2017-02-10

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