GenX – Fertility Friendly Lube- 2oz

GUDID 00796494002773

Fertility-Friendly Water-based Personal Lubricant - Unscented

CC Wellness LLC

Sexual lubricant

• Primary Device ID: 00796494002773
• NIH Device Record Key: 2a3e4b35-b324-4889-af69-f55632b742db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenX – Fertility Friendly Lube- 2oz
• Version Model Number: 72228
• Company DUNS: 067692292
• Company Name: CC Wellness 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00796494002766 [Primary]
GS1	00796494002773 [Package]; Contains: 00796494002766; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212705

FDA Product Code

• PEB: Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

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: 2023-05-22
• Device Publish Date: 2023-05-12

Devices Manufactured by CC Wellness LLC

• 00796494005422 - PlusOne Water-Based + Aloe Personal Lubricant 4oz: 2024-11-05 Water-Based Personal Lubricant
• 00796494005439 - PlusOne Coconut Hybrid 4oz: 2024-11-05 Hybrid-Based Personal Lubricant
• 00796494005446 - PlusOne Water + Silicone Personal Lubricant 4oz: 2024-11-05 Hybrid-Based Personal Lubricant
• 10796494005412 - #LubeLife Foil Core Variety Pack 10ml: 2024-11-04 Variety Pack of Personal Lubricants
• 10796494005344 - Pink Pussycat - Purrr-fect Lube - 8oz/240ml: 2024-10-21 Water-Based Personal Lubricant
• 10796494005337 - LubeLife - Silky Silicone Lubricant - 8oz / 240ml: 2024-10-08 Silicone-Based Personal Lubricant
• 10796494005313 - JO - Training Gift Pack - 3x1oz Lubricant Bottles: 2024-09-30 Water-Based Personal Lubricant
• 10796494005214 - Skins - Saudi - Bubblegum Water Based Lubricant 4.4 fl oz (130ml): 2024-09-27 Water-Based Personal Lubricant