Active3 Erection System AES 3

GUDID 04013273001915

Vaccum Erection Device for treatment of erectily dysfunction

KESSEL medintim GmbH

Penile vacuum device

• Primary Device ID: 04013273001915
• NIH Device Record Key: ba0587af-4d85-41d3-9527-40bf632fda02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Active3 Erection System
• Version Model Number: AES 3
• Catalog Number: AES 3
• Company DUNS: 537500365
• Company Name: KESSEL medintim GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +496105203720
• Email: service@medintim.de

Operating and Storage Conditions

• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04013273001915 [Primary]

FDA Product Code

• LKY: Device, External Penile Rigidity

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: 2020-02-06
• Device Publish Date: 2020-01-29

Devices Manufactured by KESSEL medintim GmbH

• 04013273000116 - Active Erection System: 2023-08-15 Vacuum Erection Device for treatment of erectile dysfunction
• 04013273001557 - Vagiwell Dilator 5er Set Premium: 2023-07-28 Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina
• 04013273001564 - Vaginal Dilator 3er Set small: 2023-07-28 Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina
• 04013273001571 - Vaginal Dilator 3er Set large: 2023-07-28 Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina
• 04013273000208 - Constriction Ring 9mm: 2022-08-04 Constriction ring or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction
• 04013273000215 - Constriction Ring 12mm: 2022-08-04 Constriction ring in 12mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction
• 04013273000222 - Constriction Ring 15mm: 2022-08-04 Constriction ring in 15mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction
• 04013273000239 - Constriction Ring 18mm: 2022-08-04 Constriction ring in 18mm or pubic ring to be use together with a vacuump pump for treatment of erectile dysfunction