FDA UDI
In Commercial Distribution
🇺🇸 United States
FLUID TRAP
DI: 10614559104477
·
Model: MGVSFT10
·
MEGADYNE MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FLUID TRAP
- Primary DI
- 10614559104477
- Version / Model
- MGVSFT10
- Catalog Number
- MGVSFT10
- Company Name
- MEGADYNE MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 185444825
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-05
- Public Version
- 9
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- a627286c-a3ca-4cd8-9ee1-002bcfec5a94
Device Description
Fluid Trap for Mini Vac Smoke Evacuator
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GAZ | Tubing, Noninvasive | General Hospital | 880.6740 | 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 |
|---|---|---|---|---|---|---|
| Primary | 10614559104477 | GS1 | ||||
| Package | 30614559104471 | GS1 | BOX | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(801)576-9669
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity