EVA 5 Insufflator

GUDID 05391536920296

Endoscopic Insufflator

PALLIARE LIMITED

Gastrointestinal endoscopic insufflator

• Primary Device ID: 05391536920296
• NIH Device Record Key: 4fa51373-8a7b-49f8-acb2-2437bcfc7bf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVA 5 Insufflator
• Version Model Number: EVA5
• Company DUNS: 985710055
• Company Name: PALLIARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	05391536920296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230474

FDA Product Code

• FCX: Insufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-24
• Device Publish Date: 2024-05-16

Devices Manufactured by PALLIARE LIMITED

• 05391536920364 - Erbe ECO2 plus: 2024-08-08 CO2 Insufflator
• 05391536920142 - EVA15: 2024-07-24 Insufflator Tubeset
• 05391536920159 - EVA15: 2024-07-24 Insufflator Tubeset
• 05391536920913 - EVA15: 2024-07-24 LAP300 Laparoscopic Insufflation Tubeset
• 05391536920944 - EVA15: 2024-07-24 Insufflator Tubeset
• 05391536920296 - EVA 5 Insufflator: 2024-05-24Endoscopic Insufflator
• 05391536920296 - EVA 5 Insufflator: 2024-05-24 Endoscopic Insufflator
• 05391536920029 - EVA15: 2023-06-20 Laparoscopic Insufflator and Smoke Evacuation System
• 05391536920081 - EndoTrap: 2023-06-20 EndoTrap Endoscopist Protection Device