InsufflationTube Set / ISO / Disposable

GUDID 04056702002633

W.O.M. World of Medicine GmbH

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 04056702002633
• NIH Device Record Key: 1d8f484b-48eb-4dad-9bef-c2ac0148fb87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InsufflationTube Set / ISO / Disposable
• Version Model Number: AR-3290-1001
• 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	04056702002626 [Primary]
GS1	04056702002633 [Package]; Contains: 04056702002626; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153513

FDA Product Code

• HIF: Insufflator, Laparoscopic

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

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