Aquoral

GUDID 10196852643216

Saliva substitue - protective oral spray

K Pharmaceuticals, LLC

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• Primary Device ID: 10196852643216
• NIH Device Record Key: 9984b18d-cfe3-4298-b53e-ab3c3ed4152b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquoral
• Version Model Number: 196852643219
• Company DUNS: 047318115
• Company Name: K Pharmaceuticals, LLC
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com
• Phone: +1(630)319-0778
• Email: info@kpharmaceutical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196852643219 [Primary]
GS1	10196852643216 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051812

FDA Product Code

• KEP: MEDIA, MOUNTING, OIL SOLUBLE

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: 2023-08-04
• Device Publish Date: 2023-07-27