PNEUVIEW XE 9660-XE

GUDID 00852588007045

LAPAROSCOPIC SMOKE ELIMINATION DEVICE

LEXION MEDICAL, LLC

Laparoscopic plume filter

• Primary Device ID: 00852588007045
• NIH Device Record Key: b4ba4b64-5687-4ec6-8fc6-8812aa9860e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PNEUVIEW XE
• Version Model Number: 9660-XE
• Catalog Number: 9660-XE
• Company DUNS: 848693730
• Company Name: LEXION MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852588007045 [Primary]

FDA Product Code

• FCZ: Tube, Smoke Removal, Endoscopic

Sterilization

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

[00852588007045]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-15

On-Brand Devices [PNEUVIEW XE]

• 00852588007052: LAPAROSCOPIC SMOKE ELIMINATION DEVICE
• 00852588007045: LAPAROSCOPIC SMOKE ELIMINATION DEVICE