EVA15 EVA15

GUDID 05391536920029

Laparoscopic Insufflator and Smoke Evacuation System

PALLIARE LIMITED

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: 05391536920029
• NIH Device Record Key: cd5e0077-11cd-4179-a4ed-49225d1eac62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVA15
• Version Model Number: EVA15
• Catalog Number: EVA15
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com
• Phone: 7606963243
• Email: jodea@palliare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391536920029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202799

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-20
• Device Publish Date: 2020-11-11

On-Brand Devices [EVA15]

• 05391536920012: LAP300 Laparoscopic Insufflation Tubeset
• 05391536920029: Laparoscopic Insufflator and Smoke Evacuation System