FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TIMM
DI: 05055140703422
·
Model: TIMM84411226-2
·
MEDIPLUS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TIMM
- Primary DI
- 05055140703422
- Version / Model
- TIMM84411226-2
- Company Name
- MEDIPLUS LTD
- Labeler DUNS
- 228480810
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2023-12-07
- Public Version Status
- Update
- Public Device Record Key
- 4dd2a8c0-1089-4a27-a8ee-0213050747aa
- Distribution End Date
- 2023-12-06
Device Description
Long water tubing kit
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEN | DEVICE, CYSTOMETRIC, HYDRAULIC | Gastroenterology, Urology | 876.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43415 | Urological irrigation system | An assembly of devices intended for the infusion of sterile fluids (e.g., saline, water) into the ureter and upper urinary tract to irrigate these passageways in a controlled manner during a diagnostic and /or a therapeutic urological procedure; including a urinary tract endoscopic procedure. It typically consists of a mains electricity (AC-powered) pump, tubing, connectors and other items that enable the pressure, temperature, or flow of water to be controlled. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 15055140703429 | GS1 | 25 | Not in Commercial Distribution | 2023-12-06 | |
| Primary | 05055140703422 | GS1 |
Customer Contacts
- Phone
- +4401494551200
- [email protected]