DEVICE: DiLumen C2 (00858836007065)

Device Identifier (DI) Information

DiLumen C2
DiLumen C2.2 130 cm
In Commercial Distribution
D-2004
LUMENDI LLC
00858836007065
GS1

1
859290897 *Terms of Use
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. This version DiLumen C2 is designed to work with the DiLumen Elbow Ig.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
FDF Colonoscope And Accessories, Flexible/Rigid
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FDA Premarket Submission

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

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a2aede89-78f8-4382-9517-f5879b776074
January 03, 2020
1
December 26, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10858836007062 5 00858836007065 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8444810822
info@lumendi.com
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