Luwi 4LUWI

GUDID B0244LUWI1

A 4-pack of Luwi Female Condoms.

LUWI, LLC

Female condom, synthetic polymer

• Primary Device ID: B0244LUWI1
• NIH Device Record Key: 91ad0308-1604-4c45-92d1-b8721d5dde05
• Commercial Distribution Discontinuation: 2025-08-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luwi
• Version Model Number: 4LUWI
• Catalog Number: 4LUWI
• Company DUNS: 079858912
• Company Name: LUWI, LLC
• Device Count: 4
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	000001 [Unit of Use]
HIBCC	B0244LUWI1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080002

FDA Product Code

• MOL: Condom, Synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-30