Caphosol

GUDID 05060146291576

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

EUSA PHARMA (UK) LIMITED

Artificial saliva

• Primary Device ID: 05060146291576
• NIH Device Record Key: ea04ca45-7f3b-42e6-be44-41fb455ba438
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caphosol
• Version Model Number: 64 x 15 mL ampules 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	05060146291576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030802

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: 2024-04-04
• Device Publish Date: 2024-03-27

Devices Manufactured by EUSA PHARMA (UK) LIMITED

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