DiLumen Endolumenal Interventional Platform D-1000

GUDID 00865309000201

DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area.

LUMENDI LLC

Colonoscope positioning sleeve

• Primary Device ID: 00865309000201
• NIH Device Record Key: deb00713-347d-4063-9b79-8ade63fc7c46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiLumen Endolumenal Interventional Platform
• Version Model Number: DiLumen
• Catalog Number: D-1000
• Company DUNS: 859290897
• Company Name: LUMENDI 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: 8444810822
• Email: info@lumendi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865309000201 [Primary]
GS1	00865309000218 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162428

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-13

Devices Manufactured by LUMENDI LLC

• 00858836007164 - DiLumen C1, 130 cm: 2023-05-09 The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine,
• 00858836007171 - DiLumen EZ1, 130 cm: 2023-05-09 The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine
• 00858836007188 - DiLumen C1, 103 cm: 2023-05-09 The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine,
• 00858836007195 - DiLumen EZ1, 103 cm: 2023-05-09 The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine
• 00858836007102 - DiLumen Interventional Grasper: 2020-09-02 125 cm flexible shaft grasper with elbow bending section and articulating distal tip
• 00858836007041 - DiLumen Ik Endolumenal Interventional Knife: 2020-02-06 The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intend
• 00858836007058 - DiLumen Ik Endolumenal Interventional Knife: 2020-02-06 The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intend
• 00858836007065 - DiLumen C2: 2020-01-03 DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind th