EVA15

GUDID 05391536920012

LAP300 Laparoscopic Insufflation Tubeset

PALLIARE LIMITED

Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use

• Primary Device ID: 05391536920012
• NIH Device Record Key: a26b477f-742f-4f32-9a7c-0c9e6cb0fa51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVA15
• Version Model Number: LAP300
• Company DUNS: 985710055
• Company Name: PALLIARE LIMITED
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@palliare.com
• Phone: 7606963243
• Email: khorgan@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
• Phone: 7606963243
• Email: jodea@palliare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391536920005 [Primary]
GS1	05391536920012 [Package]; Contains: 05391536920005; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202799

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-05-10
• Device Publish Date: 2020-11-11

On-Brand Devices [EVA15]

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