DiLumen Endolumenal Interventional Platform

Primary DI
00865309000201
Brand
DiLumen Endolumenal Interventional Platform
Company
LUMENDI LLC
Model
DiLumen
Catalog number
D-1000
Device description
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.
Published
2017-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDFColonoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162428000DiLumen Endolumenal Interventional PlatformLumendi, LLC2016-12-06FDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865309000218PackageGS15In Commercial Distribution
00865309000201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865309000218008653090002188653090002180865309000218
00865309000201008653090002018653090002010865309000201

GMDN Terms#

Term, Definition table
TermDefinition
Colonoscope positioning sleeveA non-sterile endoscopic sheath with two inflatable balloons designed to be mounted on a colonoscope to position and stabilize the endoscope within the large intestine of a patient. It is made of synthetic polymer materials and is in the form of a tubular shaft with a manually-controlled proximal handle used to inflate/deflate the two distal balloons, which upon inflation create an isolated diagnostic or therapeutic zone in the target region. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8444810822info@lumendi.com

Regulatory Flags#

DUNS number
859290897
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858836007164DiLumen C1, 130 cmDiLumen C1, 130 cmD-21002023-05-01
00858836007171DiLumen EZ1, 130 cmDiLumen EZ1, 130 cmD-11002023-05-01
00858836007188DiLumen C1, 103 cmDiLumen C1, 103 cmD-21012023-05-01
00858836007195DiLumen EZ1, 103 cmDiLumen EZ1, 103 cmD-11012023-05-01
00858836007102DiLumen Interventional GrasperIgE 125cmD-30102020-08-25
00858836007041DiLumen Ik Endolumenal Interventional KnifeDiLumen Ik 95 cmD-32002019-12-26
00858836007058DiLumen Ik Endolumenal Interventional KnifeDiLumen Ik 140 cmD-32012019-12-26
00858836007065DiLumen C2DiLumen C2.2 130 cmD-20042019-12-26
00858836007089DiLumen C2DiLumen C2.2 103 cmD-20052019-12-26
00865309000256DiLumen Ig Interventional GrasperDiLumen Ig 140 cmD-30012018-12-14
00865309000287DiLumen Ig Interventional GrasperDiLumen Ig 95 cmD-30002018-12-14
00858836007003DiLumen Im Interventional Tool MountDiLumen ImD-40002018-12-19
00865309000232DiLumen Endolumenal Interventional Platform, 103 cmDiLumen, 103 cmD-10022018-12-19
00865309000225DiLumen Endolumenal Interventional Platform, 130 cmDiLumen, 130 cmD-10012018-12-19
10865309000239DiLumen Endolumenal Interventional Platform, 103 cmDiLumen, 103 cmD-10022018-12-19
00858836007027DiLumen C2DiLumen C2 130 cmD-20012018-12-14
00858836007034DiLumen C2DiLumen C2 103 cmD-20022018-12-14
00865309000249DiLumen C2DiLumen C2 168 cmD-20002018-12-14
10858836007024DiLumen C2DiLumen C2 130 cmD-20012018-12-14
10858836007031DiLumen C2DiLumen C2 103 cmD-20022018-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973786293222Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
06973786293246Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co.,Ltd. (YinDu Road Factory)FDF2026-06-04
07290016992113Aer-O-Scope Disposable ColonoscopeG.I. VIEW LTDFDF2026-05-27
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.FDF2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.FDF2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.FDF2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.FDF2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.FDF2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.FDF2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.FDF2026-04-06
04547410566253FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566291FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566338FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566376FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566413FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410566451FUJIFILMFUJIFILM CORPORATIONFDF2026-02-27
04547410477245FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477276FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04547410477306FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04953170423628GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04953170454356DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-13
04953170454271DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454288DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454295DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454301DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454325DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12
04953170454349DISPOSABLE DISTAL ATTACHMENTOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-12