DiLumen Endolumenal Interventional Platform, 103 cm D-1002

GUDID 10865309000239

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 ID10865309000239
NIH Device Record Key38ba1a0d-f30f-428a-9b82-8beab5c67d19
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiLumen Endolumenal Interventional Platform, 103 cm
Version Model NumberDiLumen, 103 cm
Catalog NumberD-1002
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100865309000232 [Primary]
GS110865309000239 [Package]
Contains: 00865309000232
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 Date2019-01-21
Device Publish Date2018-12-19

Devices Manufactured by LUMENDI LLC

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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