ERBEFLO AeroRinse® 20325-236

GUDID 04065655001044

CO2 and Water Tubing/Cap Set for Pentax® Scopes

Erbe Medical, LLC

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 04065655001044
• NIH Device Record Key: 5f8e9641-1584-4452-a8be-a83dca551dc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERBEFLO AeroRinse®
• Version Model Number: 20325-236
• Catalog Number: 20325-236
• 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: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 Meter
• Length: 0.4 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	04050147014466 [Previous]
GS1	04065655001037 [Primary]
GS1	04065655001044 [Package]; Contains: 04065655001037; Package: Level 1 [10 Units]; In Commercial Distribution
GS1	04065655001051 [Package]; Package: Level 2 [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162152

FDA Product Code

• FEQ: Pump, Air, Non-Manual, For Endoscope

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 AeroRinse®]

• 04065655001372: Air and Water Tubing/Cap Set for Olympus® Scopes
• 04065655001280: Air and Water Tubing/Cap Set for Fujinon® Scopes
• 04065655001259: Air and Water Tubing/Cap Set for Pentax® Scopes
• 04065655001075: CO2 and Water Tubing/Cap Set for Fujinon® Scopes
• 04065655001044: CO2 and Water Tubing/Cap Set for Pentax® Scopes
• 04065655000986: CO2 and Water Tubing/Cap Set for Olympus® Scopes & UCR
• 04065655000955: CO2 and Water Tubing/Cap Set for Olympus® Scopes