OptiMumm E3645
GUDID 20884524000319
Smoke Tubing
Covidien LP
Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube Surgical plume evacuation system tube| Primary Device ID | 20884524000319 |
| NIH Device Record Key | 8530cbf1-9c36-479e-abcc-84c524d8d584 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiMumm |
| Version Model Number | E3645 |
| Catalog Number | E3645 |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 | |
| 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 | |
| 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 |
Device Dimensions
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
| Outer Diameter | 0.375 Inch |
| Length | 10 Feet |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Special Storage Condition, Specify | Between 0 and 0 *; |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884524000312 [Primary] |
| GS1 | 20884524000319 [Package] Contains: 10884524000312 Package: CASE [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K980915
FDA Product Code
| FYD | APPARATUS, EXHAUST, SURGICAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-08-17 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [OptiMumm]
| 10884524001104 | Smoke Sponge Guard Tubing |
| 20884524001095 | Smoke Prefilter |
| 10884524001081 | ULPA Filter |
| 20884524000319 | Smoke Tubing |
| 10884524001135 | Smoke Prefilter Reducer Adapter |
| 10884524001128 | Smoke Prefilter Reducer Adapter |
| 10884524001111 | Smoke Reducer Fitting |
Trademark Results [OptiMumm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTIMUMM 75828648 2461104 Live/Registered |
COVIDIEN AG 1999-10-20 |
 OPTIMUMM 75442931 not registered Dead/Abandoned |
United States Surgical Corporation 1998-03-02 |
 OPTIMUMM 75423589 not registered Dead/Abandoned |
Valleylab, Inc. 1998-01-26 |
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