| Primary Device ID | 20884521855370 | 
| NIH Device Record Key | d3350c0f-2bd7-4b06-a9b3-cd3dab307411 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Valleylab SM | 
| Version Model Number | VSMPA22 | 
| Company DUNS | 058614483 | 
| Company Name | Covidien LP | 
| Device Count | 10 | 
| DM Exempt | true | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 | 
| covidien.udi@covidien.com | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Handling Environment Temperature | Between -30 Degrees Celsius and 60 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10884521855373 [Primary] | 
| GS1 | 20884521855370 [Package] Contains: 10884521855373 Package: CASE [8 Units] In Commercial Distribution | 
| GS1 | 30884521855377 [Unit of Use] | 
| QGI | Air-Handling Apparatus Accessory | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-07-18 | 
| Device Publish Date | 2025-07-10 | 
| 20884521836386 | Smoke Management Extended Nozzle for use with 6" electrode | 
| 30884521836376 | Smoke Management Extended Nozzle for use with 4" electrode | 
| 20884521836362 | Smoke Management Pencil, Edge Coated Electrode, 15ft | 
| 20884521836355 | Smoke Management Pencil, Edge Coated Electrode, 10ft | 
| 10884521837188 | Smoke Management Pencil with Edge Blade Electrode Non-sterile Bulk, 10ft | 
| 20884521855370 | Smoke Management Pencil Adapter |