FDA UDI
In Commercial Distribution
🇺🇸 United States
VIROSAFE
DI: 20845854082802
·
Model: ASVS35302
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- VIROSAFE
- Primary DI
- 20845854082802
- Version / Model
- ASVS35302
- Catalog Number
- ASVS35302
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2020-11-02
- Public Version
- 3
- Public Version Date
- 2024-08-05
- Public Version Status
- Update
- Public Device Record Key
- ba6af61d-d936-4d8c-96cd-9e377ecd5937
Device Description
VIROSAFE SMOKE EVACUATION FILTER WITH 6.4 MM (1/4"), 9.5 MM (3/8"), AND 22 MM (7/8") PORTS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|---|---|
| Package | 30845854082472 | GS1 | BOX | 2 | In Commercial Distribution | |
| Primary | 20845854082802 | GS1 | ||||
| Unit of Use | 00845854082471 | GS1 | ||||
| Previous | 20845854060015 | GS1 |
Customer Contacts
- Phone
- +1(866)426-6633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930041 | 000 |