FDA UDI
In Commercial Distribution
🇺🇸 United States
Air/Water Channel Cleaning Adapter
DI: 00850025860666
·
Model: BW01-OLYC
·
Micro-tech Usa
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Air/Water Channel Cleaning Adapter
- Primary DI
- 00850025860666
- Version / Model
- BW01-OLYC
- Company Name
- Micro-tech Usa
- Labeler DUNS
- 079873914
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-04
- Public Version
- 1
- Public Version Date
- 2025-03-12
- Public Version Status
- New
- Public Device Record Key
- 95ae28e7-a621-4bde-b36b-5adab5fb7834
Device Description
Cleaning Valve Olympus
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
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | 876.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65552 | Endoscope flushing adaptor, single-use | A small attachment designed to be fitted to an endoscope port for flushing of the endoscope’s lumen(s) during post-procedural washing, disinfection and/or sterilization. It is in the form of a plug that may include a button/switch for control of fluid (e.g., sterilant, disinfectant) and/or air through the lumen; it does not include tubing (i.e., not a tubing set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850025860663 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 00850025860666 | GS1 | ||||
| Package | 20850025860660 | GS1 | Case | 8 | In Commercial Distribution |