Tube set for suction (with 2 ports), single-use

GUDID 04056702008840

W.O.M. World of Medicine GmbH

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 04056702008840
• NIH Device Record Key: 81638c39-3fbc-4abd-9a5a-24cd778fba08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tube set for suction (with 2 ports), single-use
• Version Model Number: OTFLWTBING
• 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	04056702008833 [Primary]
GS1	04056702008840 [Package]; Contains: 04056702008833; 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 suction (with 2 ports), single-use]

• 04056702005436: T0503-01
• 04056702008840: OTFLWTBING