ERBEFLO CleverCap® 20325-205

GUDID 04065655001327

Hybrid OFP & EndoStat Tubing/ Cap Set for Olympus® Scope

Erbe Medical, LLC

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• Primary Device ID: 04065655001327
• NIH Device Record Key: bb808c69-7663-4cc3-a203-574c4dbc95c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERBEFLO CleverCap®
• Version Model Number: 20325-205
• Catalog Number: 20325-205
• 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: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter
• Length: 3.5 Meter

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	04050147012806 [Previous]
GS1	04065655001303 [Primary]
GS1	04065655001327 [Package]; Contains: 04065655001303; Package: Level 1 [7 Units]; In Commercial Distribution
GS1	04065655001358 [Package]; Package: Level 2 [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221177

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: 2023-10-02
• Device Publish Date: 2023-09-22

On-Brand Devices [ERBEFLO CleverCap®]

• 04065655001327: Hybrid OFP & EndoStat Tubing/ Cap Set for Olympus® Scope
• 04065655001228: Hybrid Tubing/Cap Set for Fujifilm® Scopes
• 04065655001174: Hybrid Tubing/Cap Set for Pentax® Scopes
• 04065655001105: Hybrid CO2 Tubing/Cap Set for Fujinon® Scopes
• 04065655001013: Hybrid CO2 Tubing/Cap Set for Fujifilm® Scopes
• 04065655000924: CO2 Olympus® Connector Tube
• 04065655000894: CO2 Connector Tube
• 04065655000863: Hybrid CO2 Tubing/Cap Set for Pentax® Scopes
• 04065655000610: Hybrid Tubing/Cap Set for Olympus® Scopes
• 04065655000825: Hybrid CO2 Tubing/Cap Set for Olympus® Scopes
• 04065655000405: Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & UCR
• 04065655000375: Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & CO2 Sources