BioGenesis Fertility Lubricant 200401

GUDID 00893268000802

BioGenesis Fertility Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. BioGenesis Fertility Lubricant is compatible with sperm, oocytes, and embryos and can be used by trying to conceive couples. BioGenesis Fertility Lubricant is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. BioGenesis Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.

GOOD CLEAN LOVE, INC.

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• Primary Device ID: 00893268000802
• NIH Device Record Key: c15684f9-ca48-4d0f-a0c7-88f0d6619bda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioGenesis Fertility Lubricant
• Version Model Number: 5mL
• Catalog Number: 200401
• Company DUNS: 153909531
• Company Name: GOOD CLEAN LOVE, INC.
• 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	00850014621971 [Package]; Package: Sample Case [100 Units]; In Commercial Distribution
GS1	00850044065097 [Package]; Package: Case [100 Units]; In Commercial Distribution
GS1	00893268000802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190872

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: 2023-04-11
• Device Publish Date: 2023-04-03

On-Brand Devices [BioGenesis Fertility Lubricant]

• 30893268000674: 2oz
• 00893268000802: BioGenesis Fertility Lubricant is a personal lubricant for penile and/or vaginal application, in