DiLumen C2 D-2001

GUDID 10858836007024

DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. 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. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions.

LUMENDI LLC

Colonoscope positioning sleeve

• Primary Device ID: 10858836007024
• NIH Device Record Key: b1b78bba-f4a3-43a9-b037-3fc5e3ca67c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DiLumen C2
• Version Model Number: DiLumen C2 130 cm
• Catalog Number: D-2001
• 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	00858836007027 [Primary]
GS1	10858836007024 [Package]; Contains: 00858836007027; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173317

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid

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: 2019-01-14
• Device Publish Date: 2018-12-14

On-Brand Devices [DiLumen C2]

• 10865309000246: DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device emp
• 10858836007031: DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device emp
• 10858836007024: DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device emp
• 00858836007089: DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device emp
• 00858836007065: DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device emp