FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Endoscopy Valve Set
DI: 06936603226902
·
Model: FTL-VS-PI20-J
·
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Endoscopy Valve Set
- Primary DI
- 06936603226902
- Version / Model
- FTL-VS-PI20-J
- Catalog Number
- 115281
- Company Name
- Yangzhou Fartley Medical Instrument Technology Co., Ltd
- Labeler DUNS
- 544375774
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-21
- Public Version
- 1
- Public Version Date
- 2025-08-29
- Public Version Status
- New
- Public Device Record Key
- 73b45afb-a6de-4f69-b139-bbc5c988d1a0
Device Description
PENTAX i20 type: Cleaning Valve
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
- Yes
- 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 |
|---|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60760 | Endoscope channel support kit | A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16936603226909 | GS1 | Sales Packaging | 100 | In Commercial Distribution | |
| Primary | 06936603226902 | GS1 | ||||
| Package | 26936603226906 | GS1 | Shipping Carton | 4 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220210 | 000 |