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 |
Phone | 8444810822 |
info@lumendi.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00865309000201 [Primary] |
GS1 | 00865309000218 [Package] Package: Box [5 Units] In Commercial Distribution |
FDF | Colonoscope And Accessories, Flexible/Rigid |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-06-13 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM 87255341 not registered Live/Pending |
Lumendi Ltd. 2016-12-02 |