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DiLumen Endolumenal Interventional Platform
FDA UDIClass II (US FDA UDI)
by Lumendi Llc
Identity
- Trade Name
- DiLumen Endolumenal Interventional Platform FDA UDI
- Generic Name
- Colonoscope positioning sleeve FDA UDI
- Device Name
- 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
- Model / Reference
- DiLumen 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-1000 FDA UDI
- Primary DI / UDI-DI
- 00865309000201 FDA UDI
- 510(k) Number
- K162428 FDA UDI
- FDA Product Code
- FDF FDA UDI
- GMDN Term
- Colonoscope positioning sleeve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colonoscope positioning sleeve
DiLumen Endolumenal Interventional Platform by Lumendi Llc — Class II — FDA UDI — listed in FDA GUDID — 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 Endolumenal Interventional Platform, 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
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lumendi Llc
Sources (1)
- FDA UDI deb00713-347d-4063-9b79-8ade63fc7c46 36 fields · synced Jun 1, 2026