SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHg FD-1003

GUDID 05391530750059

Saphenous Vein Distention System - 200mmHg - Sterile

DMC MEDICAL LIMITED

Vein irrigation/distention set

• Primary Device ID: 05391530750059
• NIH Device Record Key: 506dfd9e-d6aa-45c1-b748-55165a5ab84d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHg
• Version Model Number: SVDS200
• Catalog Number: FD-1003
• Company DUNS: 989772017
• Company Name: DMC MEDICAL LIMITED
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530750035 [Primary]
GS1	05391530750042 [Package]; Contains: 05391530750035; Package: [5 Units]; In Commercial Distribution
GS1	05391530750059 [Package]; Contains: 05391530750042; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000704

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-10

Devices Manufactured by DMC MEDICAL LIMITED

• 05391530750059 - SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHg: 2018-07-06Saphenous Vein Distention System - 200mmHg - Sterile
• 05391530750059 - SVDS200 SAPHENOUS VEIN DISTENTION SYSTEM - 200mmHg: 2018-07-06 Saphenous Vein Distention System - 200mmHg - Sterile
• 05391530750080 - SVDS300 SAPHENOUS VEIN DISTENTION SYSTEM - 300mmHg: 2018-07-06 Saphenous Vein Distention System - 300mmHg - Sterile
• 05391530750110 - Vein Irrigation Cannula DMC VIC Sterile: 2018-07-06 Vein Irrigation Cannula Sterile
• 05391530750141 - Cardiac Insulation Pad Adult Sterile: 2018-07-06 Cardiac Insulation Pad Adult Sterile
• 05391530750172 - 1ml Insulin Suresafe Syringe: 2018-07-06 1ml Insulin Automatic Retractable Syringe - 29G x 1/2" - Sterile
• 05391530750202 - 1ml Tuberculin Suresafe Syringe: 2018-07-06 1ml Tuberculin Automatic Retractable Safety Syringe - 27G x 1/2" - Sterile
• 05391530750233 - 1ml Tuberculin Suresafe Syringe: 2018-07-06 1ml Tuberculin Automatic Retraction Safety Syringe - 25G x 5/8" - Sterile
• 05391530750264 - 1ml Tuberculin Suresafe Syringe: 2018-07-06 1ml Tuberculin Suresafe Automatic Retractable Safety Syringe - 25G x 1" - Sterile