VIVA Pump VP01

GUDID 08809306769015

The peristaltic pump, VIVA Pump, is used to provide the cooling of the electrodes, star RF Electrode. The chilled water is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is enclosed system within the electrode and the water is not to be in contact with the patient.

STARMED CO.,LTD

Cooling utility supply system

• Primary Device ID: 08809306769015
• NIH Device Record Key: 10e7dd4d-e5f1-414f-8254-5061015e0e21
• Commercial Distribution Discontinuation: 2019-07-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VIVA Pump
• Version Model Number: VP01
• Catalog Number: VP01
• Company DUNS: 694699723
• Company Name: STARMED 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: 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

Customer Support Contacts

• Phone: +82318163546
• Email: inquiry@starmed4u.com

Device Dimensions

• Width: 193 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809306769015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163450

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-05
• Device Publish Date: 2017-05-19

Devices Manufactured by STARMED CO.,LTD

• 08809922260620 - ELRA Electrode: 2023-12-04
• 08809922260644 - ELRA Electrode: 2023-12-04
• 08809922260651 - ELRA Electrode: 2023-12-04
• 08809922260668 - ELRA Electrode: 2023-12-04
• 08809922260675 - ELRA Electrode: 2023-12-04
• 08809922260682 - ELRA Electrode: 2023-12-04
• 08809922260699 - ELRA Electrode: 2023-12-04
• 08809306767349 - star RF Electrode: 2022-06-10 The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF G