DEFENDO 00711900

GUDID 10724995197688

The single-use DEFENDO Olympus EUS Air Water Suction valve - 2-piece kit is used to control the air/water function of an endoscope during a GI procedure.

US Endoscopy

Endoscope channel support kit

• Primary Device ID: 10724995197688
• NIH Device Record Key: 4c92ebd1-9390-4e4d-9eab-97a988364813
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEFENDO
• Version Model Number: 00711900
• Catalog Number: 00711900
• Company DUNS: 627879687
• Company Name: US Endoscopy
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995197681 [Primary]
GS1	10724995197688 [Package]; Contains: 00724995197681; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202104

FDA Product Code

• ODC: Endoscope channel accessory

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: 2024-07-23
• Device Publish Date: 2024-07-15

On-Brand Devices [DEFENDO]

• 10724995217409: The single-use DEFENDO Olympus EUS Air Water Suction Valve - Linear Biopsy Valve 3-piece kit
• 10724995197688: The single-use DEFENDO Olympus EUS Air Water Suction valve - 2-piece kit is used to control the