Frida Fertility

GUDID 10810028774121

Fridababy, LLC

Conceptive cervical cap, reusable

• Primary Device ID: 10810028774121
• NIH Device Record Key: 7736ec9b-ebd7-4d73-b288-dd33c7a930ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Frida Fertility
• Version Model Number: 500001269
• Company DUNS: 783729598
• Company Name: Fridababy, 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: 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	00810028774124 [Primary]
GS1	10810028774121 [Package]; Contains: 00810028774124; Package: Box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222969

FDA Product Code

• HDR: Cap, Cervical

Sterilization

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

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

[10810028774121]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-13
• Device Publish Date: 2023-12-05

Devices Manufactured by Fridababy, LLC

• 00810028776166 - Frida: 2024-09-20 Fertility Friendly Lubricant
• 10810028774084 - Frida: 2024-09-20 Early Detection Pregnancy Tests
• 10810028774121 - Frida Fertility: 2023-12-13
• 10810028774121 - Frida Fertility: 2023-12-13