ERBEFLO® 2 20325-212

GUDID 04065655000177

Endoscopy Port Connector for Pentax® Scopes

Erbe Medical, LLC

Surgical irrigation tubing set, single-use

• Primary Device ID: 04065655000177
• NIH Device Record Key: a9211c41-ebd7-40a4-a2a5-f799a5c3ceb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERBEFLO® 2
• Version Model Number: 20325-212
• Catalog Number: 20325-212
• 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: false
• 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
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com
• Phone: 1-770-955-4400
• Email: technicalservice@erbe-usa.com

Device Dimensions

• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter
• Length: 70 Millimeter

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
• 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	04050147012868 [Previous]
GS1	04065655000160 [Primary]
GS1	04065655000177 [Package]; Contains: 04065655000160; Package: Level 1 [10 Units]; In Commercial Distribution
GS1	04065655000184 [Package]; Package: Level 2 [5 Units]; In Commercial Distribution

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: 2021-12-10
• Device Publish Date: 2021-12-02

On-Brand Devices [ERBEFLO® 2]

• 04065655000351: Endoscopy Channel Adapter
• 04065655000320: Endoscopy OFP & EndoStat Pump Tubing/Cap Set
• 04065655000290: Endoscopy Pump Tubing/ Cap Set for Fujinon® Scopes
• 04065655000269: Endoscopy Pump Tubing/Cap Set
• 04065655000238: Endo Quick Connect Pentax® Scope Port Connector
• 04065655000207: Back Flow Valve
• 04065655000177: Endoscopy Port Connector for Pentax® Scopes
• 04065655000146: Endo. Port Connector w/Valve for Olympus® Scopes
• 04065655000115: Endoscopy Port Connector for Olympus® Scopes