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 ID10858836007024
NIH Device Record Keyb1b78bba-f4a3-43a9-b037-3fc5e3ca67c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiLumen C2
Version Model NumberDiLumen C2 130 cm
Catalog NumberD-2001
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
GS100858836007027 [Primary]
GS110858836007024 [Package]
Contains: 00858836007027
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 Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-14
Device Publish Date2018-12-14

On-Brand Devices [DiLumen C2]

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

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