FDA UDI
In Commercial Distribution
🇺🇸 United States
DEFENDO Air/Water and Suction Valves
DI: 00677964055935
·
Model: 100317
·
MEDIVATORS INC.
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- DEFENDO Air/Water and Suction Valves
- Primary DI
- 00677964055935
- Version / Model
- 100317
- Company Name
- MEDIVATORS INC.
- Labeler DUNS
- 068199363
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 8
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 1862ccae-e959-4548-860a-32c23fdc4555
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 60759 | Endoscopic suction valve, single-use | A device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a single-use device. | No | Active |
| 60758 | Endoscopic procedure air/water valve, single-use | A sterile device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] for insufflation, and/or water for irrigation, whilst preventing backflow. It is in the form of an attachable inflow valve with closed and open settings. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00677964055935 | GS1 | ||||
| Package | 20677964055939 | GS1 | Case | 100 | In Commercial Distribution | |
| Package | 10677964055932 | GS1 | Carton | 50 | In Commercial Distribution |