OptiMumm E3645
GUDID 20884524000319
Smoke Tubing
Covidien LP
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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