PNEUMOCLEAR

GUDID 04056702001308

W.O.M. World of Medicine GmbH

Laparoscopic insufflator

• Primary Device ID: 04056702001308
• NIH Device Record Key: a46db86a-8a9d-47bf-a015-b43de8f0514d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNEUMOCLEAR
• Version Model Number: FM300
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	04056702001308 [Primary]

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: false

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

On-Brand Devices [PNEUMOCLEAR]

• 04056702003456: FM300
• 04056702003432: FM300
• 04056702003401: FM300
• 04056702001308: FM300