Allday Gel 2 pk

GUDID 00858290006635

Allday Gel 2 pk

ELEVATE ORAL CARE, LLC

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: 00858290006635
• NIH Device Record Key: 90363cac-61ee-49c9-9af0-35e6475eb9fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allday Gel 2 pk
• Version Model Number: 626GEL210
• Company DUNS: 002863526
• Company Name: ELEVATE ORAL CARE, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150074

FDA Product Code

• LFD: Saliva, Artificial

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-04-29
• Device Publish Date: 2021-05-28

Devices Manufactured by ELEVATE ORAL CARE, LLC

• 00858290006895 - Povi-One: 2023-10-05 Povi-One Unit Dose, .45ml, Demo 2pk
• 00858290006888 - Advantage Arrest: 2023-07-31 Advantage Arrest, Convenience Kit
• 00858290006871 - Allday Spray/Gel Sample Bag: 2023-05-26 Dry Mouth Spray and Gel, Mint, 1.5oz Bottle and Tube, Sample Bag
• 00858290006758 - FluoriMax 2.5% NaF Varnish: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Bubble Gum
• 00858290006765 - FluoriMax 2.5% NaF Varnish: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Mint
• 00858290006772 - FluoriMax 2.5% NaF Varnish: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Caramel
• 00858290006789 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored
• 00858290006796 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy