HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET

GUDID 04056702001513

W.O.M. World of Medicine GmbH

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 04056702001513
• NIH Device Record Key: 6acaa7a6-530c-4237-8c2e-0d63b0125bfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET
• Version Model Number: 0620050350
• Company DUNS: 316305242
• Company Name: W.O.M. World of Medicine GmbH
• 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	04056702001506 [Primary]
GS1	04056702001513 [Package]; Contains: 04056702001506; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170784

FDA Product Code

• OSV: Insufflator, Endoscopic Vessel Harvesting

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: 2017-05-24

Devices Manufactured by W.O.M. World of Medicine GmbH

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• 04056702008802 - Tube set for insufflation, single-use: 2020-11-09
• 04056702008826 - Tube set for suction, single-use: 2020-11-09
• 04056702008840 - Tube set for suction (with 2 ports), single-use: 2020-11-09
• 04056702008864 - Tube set for irrigation, single-use: 2020-11-09
• 04056702008888 - Tube set for vacuum incl. filter, 30-day use: 2020-11-09