Tube set for vacuum incl. filter, 30-day use

GUDID 04056702008888

W.O.M. World of Medicine GmbH

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• Primary Device ID: 04056702008888
• NIH Device Record Key: c0f2aa3e-f7bb-4dfe-98a9-32f27f4dfd22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tube set for vacuum incl. filter, 30-day use
• Version Model Number: INTUBWVACC
• 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	04056702008871 [Primary]
GS1	04056702008888 [Package]; Contains: 04056702008871; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173489

FDA Product Code

• HIG: Insufflator, Hysteroscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-09
• Device Publish Date: 2020-11-01

On-Brand Devices [Tube set for vacuum incl. filter, 30-day use]

• 04056702005412: T0504-01
• 04056702008888: INTUBWVACC