PowerPumpTM dp System

GUDID 17350021986105

Medical Vision AB

Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system Arthroscopic irrigation/insufflation system

• Primary Device ID: 17350021986105
• NIH Device Record Key: 59d1f784-d9a6-4271-b48e-bfd5754dff88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerPumpTM dp System
• Version Model Number: 941010
• Company DUNS: 508778565
• Company Name: Medical Vision AB
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17350021986105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093409

FDA Product Code

• HRX: Arthroscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by Medical Vision AB

• 17350021987003 - PowerPumpTM dp System Day Cassette: 2019-04-23
• 17350021987027 - PowerPumpTM dp System Patient cassette: 2019-04-23
• 17350021987058 - PowerPumpTM dp System Patient tubing: 2019-04-23
• 07350021981202 - Double Pump Day cassette/ Double Pump RF Day cassette: 2019-04-23
• 07350021981523 - Double Pump Single/ Double Pump RF Single: 2019-04-23
• 07350021982209 - Double Pump Patient cassette: 2019-04-23
• 07350021982704 - Double Pump RF Patient cassette: 2019-04-23
• 17350021986105 - PowerPumpTM dp System: 2018-07-06
• 17350021986105 - PowerPumpTM dp System: 2018-07-06