FDA UDI
In Commercial Distribution
🇺🇸 United States
CONMED BUFFALO FILTER
DI: 20845854081751
·
Model: 395-703
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
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Basic Information
- Brand Name
- CONMED BUFFALO FILTER
- Primary DI
- 20845854081751
- Version / Model
- 395-703
- Catalog Number
- 395-703
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2024-03-25
- Public Version
- 2
- Public Version Date
- 2024-08-19
- Public Version Status
- Update
- Public Device Record Key
- b70e767a-ae07-4842-9c7e-99c537c3d8ee
Device Description
ULPA Charcoal Filter for MiniVac Smoke Evacuator
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FYD | APPARATUS, EXHAUST, SURGICAL | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44979 | Surgical plume evacuation system filter | A screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00845854081757 | GS1 | ||||
| Primary | 20845854081751 | GS1 | ||||
| Previous | 00815198012649 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]