FDA UDI
In Commercial Distribution
🇺🇸 United States
FUJIFILM medwork
DI: 04044503055828
·
Model: VAL1-G7-50
·
FUJIFILM medwork GmbH
Product Codes
2
GMDN Terms
3
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- FUJIFILM medwork
- Primary DI
- 04044503055828
- Version / Model
- VAL1-G7-50
- Catalog Number
- VAL1-G7-50
- Company Name
- FUJIFILM medwork GmbH
- Labeler DUNS
- 330797395
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-21
- Public Version
- 4
- Public Version Date
- 2024-07-25
- Public Version Status
- Update
- Public Device Record Key
- f9ad0083-51fb-48c9-8459-a017d3fb514e
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 876.1500 | 2 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60758 | Endoscope air/water valve, single-use | A 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 |
| 60759 | Endoscope 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 |
| 62145 | Endoscope working-channel valve, single-use | A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04044503055828 | GS1 | ||||
| Package | 14044503055825 | GS1 | cardboard box | 50 | In Commercial Distribution |
Customer Contacts
- Phone
- 800 385 4666
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210625 | 000 |