PNEUMOCLEAR

GUDID 04056702003432

W.O.M. World of Medicine GmbH

Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator Laparoscopic insufflator

• Primary Device ID: 04056702003432
• NIH Device Record Key: cf7b8f60-d1b3-4186-b744-14181f7eb033
• 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	04056702003432 [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