SalivaMAX

GUDID 00370275629047

SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a solution with a high concentration of electrolytes similar to that of natural saliva. SalivaMAX is an artificial saliva that is used to relieve acute and chronic symptoms of xerostomia and mucositis.

Forward Science Technologies LLC

Artificial saliva

• Primary Device ID: 00370275629047
• NIH Device Record Key: 62209ebd-6a9b-449e-af2c-96022237c862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SalivaMAX
• Version Model Number: SalivaMAX 30ct – 04 NDC
• Company DUNS: 079212068
• Company Name: Forward Science Technologies LLC
• 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: true
• 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	00370275629047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152406

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: 2024-02-22
• Device Publish Date: 2024-02-14

On-Brand Devices [SalivaMAX]

• 00370275629306: SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a s
• 00370275629122: SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a s
• 00370275629030: SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a s
• 00370275629047: SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a s