DiLumen Endolumenal Interventional Platform, 103 cm
FDA UDIEUDAMEDClass II (US FDA UDI)
by Lumendi Llc
Identity
- Trade Name
- DiLumen Endoluminal Interventional Platform 103 cm EUDAMEDDiLumen Endolumenal Interventional Platform, 103 cm FDA UDI
- Generic Name
- Colonoscope positioning sleeve FDA UDI
- Device Name
- DiLumen Endoluminal Interventional Platform EUDAMEDDiLumen 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. FDA UDI
- Model / Reference
- D-1002 EUDAMEDDiLumen, 103 cm FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- D-1002 FDA UDI
- Primary DI / UDI-DI
- 00865309000232 EUDAMEDFDA UDI
- Basic UDI-DI
- 08653090002DILUMENB5 EUDAMED
- 510(k) Number
- K182540 FDA UDI
- FDA Product Code
- FDF FDA UDI
- EMDN Code
- G0280 GASTROINTESTINAL TUBES - ACCESSORIES EUDAMED
- GMDN Term
- Colonoscope positioning sleeve FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Colonoscope positioning sleeve
DiLumen Endolumenal Interventional Platform, 103 cm by Lumendi Llc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Colonoscope positioning sleeve.
- DiLumen C2 — LUMENDI LLC · Class II
- DiLumen C1, 130 cm — LUMENDI LLC · Class II
- DiLumen C2 — LUMENDI LLC · Class II
- DiLumen EZ1, 103 cm — LUMENDI LLC · Class II
- DiLumen EZ1, 130 cm — LUMENDI LLC · Class II
- DiLumen C2 — LUMENDI LLC · Class II
- DiLumen C2 — LUMENDI LLC · Class II
- DiLumen C2 — LUMENDI LLC · Class II
Cleared under the same submission
K182540 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lumendi Llc
Sources (2)
- FDA UDI 38ba1a0d-f30f-428a-9b82-8beab5c67d19 36 fields · synced Jul 12, 2026
- EUDAMED 308127b8-2a4e-4c6a-9df2-e107ca38c848 61 fields · synced Jul 12, 2026