Xerostom® Saliva Substitute Gel

GUDID 08426181972769

XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. XEROSTOM® may be used to replace normal saliva, when salivary glands are damaged or not functioning. XEROSTOM® relieves the problems of dry mouth

BIO COSMETICS SL

Artificial saliva

• Primary Device ID: 08426181972769
• NIH Device Record Key: 23e244c1-03a3-4146-98ed-4d07bf5afe9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xerostom® Saliva Substitute Gel
• Version Model Number: Tube 25ml
• Company DUNS: 513423178
• Company Name: BIO COSMETICS SL
• 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: false
• 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: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Use within three months after first opening. Use before expiration date.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426181972769 [Primary]

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: 2024-04-09
• Device Publish Date: 2024-04-01