Encore 44020-001

GUDID 00850358007080

Vacuum Erection Device

ENCORE, INC.

Penile vacuum device

• Primary Device ID: 00850358007080
• NIH Device Record Key: 3da67fe5-d0b2-4935-ab57-86bac28840ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Encore
• Version Model Number: Deluxe VTU-E
• Catalog Number: 44020-001
• Company DUNS: 614647725
• Company Name: ENCORE, INC.
• 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: true
• Serial Number: false
• 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: true

Customer Support Contacts

• Phone: 800-475-3091
• Email: info@revivepremium.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850358007080 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

On-Brand Devices [Encore]

• 00850358007424: 44017-UNM- Vacuum Erection Device - 3 kits
• 00850358007417: 44017-UNB- Vacuum Erection Device - 3 kits
• 00850358007400: 44017-RETNP- Vacuum Erection Device - 3 kits
• 00850358007394: 44010-001 20/Master
• 00850358007387: 44010-100 12/Master
• 00850358007370: 44014-Manual 12/Master
• 00850358007363: 44019-001 20/Master
• 00850358007356: 44016-Battery 12/Master
• 00850358007332: 44023-001 50/Master
• 00850358007325: Case of 12 devices
• 00850358007318: Case of 12 devices
• 00850358007301: Case of 12 devices
• 00850358007295: Case of 12 devices
• 00850358007127: Manual vacuum erection device
• 00850358007110: Battery vacuum erection device
• 00850358007103: Manual vacuum erection device and battery vacuum erection device
• 00850358007080: Vacuum Erection Device
• 00850358007059: Battery Vacuum Erection Device
• 00850358007042: Manual Vacuum Erection Device
• 00850358007011: Manual Vacuum Erection Device