AccessGUDID - DEVICE: DiLumen C2 (00858836007027)

GUDID

Device Identifier (DI) Information

Brand Name: DiLumen C2
Version or Model: DiLumen C2 130 cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D-2001
Company Name: LUMENDI LLC

Primary DI Number: 00858836007027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 859290897 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62554	Colonoscope positioning sleeve	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDF	Colonoscope And Accessories, Flexible/Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173317	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b1b78bba-f4a3-43a9-b037-3fc5e3ca67c8
Public Version Date: January 14, 2019
Public Version Number: 1
DI Record Publish Date: December 14, 2018