Caphosol® Artifical Saliva

GUDID 05060146293129

Caphosol® is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol® A) and a calcium solution (Caphosol® B) which when both sachet solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions.

EUSA PHARMA (UK) LIMITED

Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva

• Primary Device ID: 05060146293129
• NIH Device Record Key: 6b240093-6e69-4fe9-99ab-b10ba56ee393
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caphosol® Artifical Saliva
• Version Model Number: 64 x 15 mL sachets aqueous solution
• Company DUNS: 220512050
• Company Name: EUSA PHARMA (UK) LIMITED
• Device Count: 1
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060146293129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234015

FDA Product Code

• LFD: Saliva, Artificial

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: 2024-07-04
• Device Publish Date: 2024-06-26

Devices Manufactured by EUSA PHARMA (UK) LIMITED

• 05060146293129 - Caphosol® Artifical Saliva: 2024-07-04Caphosol® is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol® A) and a calcium solution (Caphosol® B) which when both sachet solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions.
• 05060146293129 - Caphosol® Artifical Saliva: 2024-07-04 Caphosol® is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol® A) and a calc
• 05060146291576 - Caphosol: 2024-04-04 Caphosol is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol A) and a calcium