FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TeleVac2
DI: 00815198012526
·
Model: 5000194
·
Buffalo Filter
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TeleVac2
- Primary DI
- 00815198012526
- Version / Model
- 5000194
- Company Name
- Buffalo Filter
- Labeler DUNS
- 787855907
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2022-04-22
- Public Version Status
- Update
- Public Device Record Key
- 3c4dad64-bdc3-4b67-8537-9f4459b2250f
- Distribution End Date
- 2022-04-21
Device Description
Start-Up Kit with the following components: Multi-Port ULPA Filter - 00815198012489, Footswitch - 00851136002969, EZLink - 00815198011079, Reducer Fitting - 00851136002976, Smoke Evacuation Tubing with Connectors - 00851136002150, Y-Adapter - 00851136002365, PlumePort SE - 00851136002433, PlumePort SEV - 00851136002587, Smoke Evacuation Tubing - 00851136002235, PenAdapt - 00851136002143, and Smoke Evacuation Tubing with Wand - 00851136002068
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 46483 | Surgical plume evacuation system tube | A sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815198012526 | GS1 |
Customer Contacts
- Phone
- 716-835-7000
- [email protected]