FDA UDI
In Commercial Distribution
🇺🇸 United States
DiLumen Endolumenal Interventional Platform, 130 cm
DI: 00865309000225
·
Model: DiLumen, 130 cm
·
LUMENDI LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DiLumen Endolumenal Interventional Platform, 130 cm
- Primary DI
- 00865309000225
- Version / Model
- DiLumen, 130 cm
- Catalog Number
- D-1001
- Company Name
- LUMENDI LLC
- Labeler DUNS
- 859290897
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-19
- Public Version
- 1
- Public Version Date
- 2019-01-21
- Public Version Status
- New
- Public Device Record Key
- 6bb9ccfa-c846-4e07-b420-7f5c087e5709
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00865309000225 | GS1 | ||||
| Package | 10865309000222 | GS1 | Box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 8444810822
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182540 | 000 |