DiLumen C1, 130 cm D-2100

GUDID 00858836007164

The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen C1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope. The device also has one integrated, flexible tool channel that provides access at the therapeutic site to use flexible endoscopic tools such as graspers, scissors, knives, etc., to perform endoluminal interventions.

LUMENDI LLC

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Primary Device ID00858836007164
NIH Device Record Key146cd293-3fb8-43f7-be6c-37909fed1921
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiLumen C1, 130 cm
Version Model NumberDiLumen C1, 130 cm
Catalog NumberD-2100
Company DUNS859290897
Company NameLUMENDI LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com
Phone8444810822
Emailinfo@lumendi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858836007164 [Primary]
GS110858836007161 [Package]
Package: box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDFColonoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-09
Device Publish Date2023-05-01

Devices Manufactured by LUMENDI LLC

00858836007164 - DiLumen C1, 130 cm2023-05-09The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment. The DiLumen C1 consists of a soft flexible sheath that fits over standard endoscopes. The device employs a single balloon behind the bending section of the endoscope. When the balloon is inflated it contacts the intestine wall and provides stability to the endoscope. The device also has one integrated, flexible tool channel that provides access at the therapeutic site to use flexible endoscopic tools such as graspers, scissors, knives, etc., to perform endoluminal interventions.
00858836007164 - DiLumen C1, 130 cm2023-05-09 The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine,
00858836007171 - DiLumen EZ1, 130 cm2023-05-09 The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine
00858836007188 - DiLumen C1, 103 cm2023-05-09 The Lumendi DiLumen C1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine,
00858836007195 - DiLumen EZ1, 103 cm2023-05-09 The Lumendi DiLumen EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine
00858836007102 - DiLumen Interventional Grasper2020-09-02 125 cm flexible shaft grasper with elbow bending section and articulating distal tip
00858836007041 - DiLumen Ik Endolumenal Interventional Knife2020-02-06 The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intend
00858836007058 - DiLumen Ik Endolumenal Interventional Knife2020-02-06 The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intend
00858836007065 - DiLumen C22020-01-03 DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind th
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