Aowawo

GUDID 06925634009011

Suzhou Colourway New Material Co., Ltd.

Basic male condom, Hevea-latex

• Primary Device ID: 06925634009011
• NIH Device Record Key: c46faeff-3d26-436b-8503-e5c0d26b9868
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aowawo
• Version Model Number: 3 in 1 Male Latex Condoms, medium (53 ± 2mm) thick
• Company DUNS: 544612070
• Company Name: Suzhou Colourway New Material Co., Ltd.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06925634009011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222611

FDA Product Code

• HIS: Condom

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: 2025-08-29
• Device Publish Date: 2025-08-21

Devices Manufactured by Suzhou Colourway New Material Co., Ltd.

• 06925634009011 - Aowawo: 2025-08-29
• 06925634009011 - Aowawo: 2025-08-29
• 06925634004504 - GETANE: 2025-06-18
• 06925634004511 - GETANE: 2025-06-18
• 06925634004061 - GETANE: 2025-04-11
• 06925634004078 - GETANE: 2025-04-11
• 06925634004085 - GETANE: 2025-04-11
• 06925634004092 - GETANE: 2025-04-11
• 06925634004030 - GETANE: 2025-04-10