SwiftSet
GUDID 30884521196777
Topical Skin Adhesive
Covidien LP
Skin-approximation adhesive| Primary Device ID | 30884521196777 |
| NIH Device Record Key | 89c44d4e-6763-4913-97ee-04298b007e6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SwiftSet |
| Version Model Number | SS6 |
| 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 |
Device Dimensions
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
| Total Volume | 0.8 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521196773 [Primary] |
| GS1 | 20884521196770 [Package] Contains: 10884521196773 Package: PACK_OR_INNER_PACK [6 Units] In Commercial Distribution |
| GS1 | 30884521196777 [Package] Contains: 20884521196770 Package: CASE [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122446
FDA Product Code
| MPN | Tissue adhesive for the topical approximation of skin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-05-20 |
| Device Publish Date | 2017-01-07 |
Devices Manufactured by Covidien LP
| 20884521837468 - DAR | 2025-02-18 Adult-Pediatric Electrostatic Filter HME Small, Tethered Cap |
| 20884521837482 - DAR | 2025-02-18 Adult-Pediatric Electrostatic Filter HME with Connector Small, Tethered Cap |
| 20884521827636 - EEA | 2025-02-17 CIR STPLR TRIEEAXL21MT wTRISTP nORVL |
| 20884521827643 - EEA | 2025-02-17 CIR STPLR TRIEEAXL21XT BLK wTRISTP nORVL |
| 20884521827650 - EEA | 2025-02-17 CIR STPLR TRIEEAXL25MT wTRISTP nORVL |
| 20884521827667 - EEA | 2025-02-17 CIR STPLR TRIEEAXL25XT BLK wTRISTP nORVL |
| 20884521828992 - DAR | 2025-02-17 Adult Electrostatic Filter HME Large |
| 20884521829029 - DAR | 2025-02-17 Adult Electrostatic Filter HME with Catheter Mount Large |
Trademark Results [SwiftSet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
SWIFTSET 98705772 not registered Live/Pending |
Satori Home Limited 2024-08-19 |
 SWIFTSET 97635352 not registered Live/Pending |
Satori Home Limited 2022-10-17 |
 SWIFTSET 86698111 5365413 Live/Registered |
Tech Flo Consulting, LLC 2015-07-20 |
 SWIFTSET 86061363 4545274 Live/Registered |
Covidien LP 2013-09-11 |
 SWIFTSET 76093144 2471641 Live/Registered |
Mity-Lite, Inc. 2000-07-19 |
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