ERBEFLO® 20325-225

GUDID 04065655001396

Olympus® Scope Port Connector

Erbe Medical, LLC

Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use

• Primary Device ID: 04065655001396
• NIH Device Record Key: 2a1152c9-f1aa-4e49-9341-fba1c049d155
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERBEFLO®
• Version Model Number: 20325-225
• Catalog Number: 20325-225
• Company DUNS: 117862528
• Company Name: Erbe Medical, LLC
• 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: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat and direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	04050147021891 [Previous]
GS1	04065655001396 [Primary]
GS1	04065655001402 [Package]; Package: Level 1 [10 Units]; In Commercial Distribution
GS1	04065655001419 [Package]; Contains: 04065655001402; Package: Level 2 [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182444

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-19
• Device Publish Date: 2023-10-11

Devices Manufactured by Erbe Medical, LLC

• 04065655001396 - ERBEFLO®: 2023-10-19Olympus® Scope Port Connector
• 04065655001396 - ERBEFLO®: 2023-10-19 Olympus® Scope Port Connector
• 04065655000375 - ERBEFLO CleverCap®: 2023-10-02 Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & CO2 Sources
• 04065655000405 - ERBEFLO CleverCap®: 2023-10-02 Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & UCR
• 04065655000825 - ERBEFLO CleverCap®: 2023-10-02 Hybrid CO2 Tubing/Cap Set for Olympus® Scopes
• 04065655000610 - ERBEFLO CleverCap®: 2023-10-02 Hybrid Tubing/Cap Set for Olympus® Scopes
• 04065655000863 - ERBEFLO CleverCap®: 2023-10-02 Hybrid CO2 Tubing/Cap Set for Pentax® Scopes
• 04065655000894 - ERBEFLO CleverCap®: 2023-10-02 CO2 Connector Tube
• 04065655000924 - ERBEFLO CleverCap®: 2023-10-02 CO2 Olympus® Connector Tube