The Sequel™
GUDID 00821684058060
ACCESSORY MVA200 Y-CONNECTORS V03
Covidien LP
Angioplasty catheter connector| Primary Device ID | 00821684058060 |
| NIH Device Record Key | fd959789-c86c-4043-92c7-20044f64f4c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Sequel™ |
| Version Model Number | MVA200 |
| Company DUNS | 968903703 |
| 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 | false |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Catheter Gauge | 9 French |
| Outer Diameter | 3 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684058060 [Primary] |
| GS1 | 00821684073988 [Package] Package: PK [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K914046
FDA Product Code
| DYB | INTRODUCER, CATHETER |
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 | 2020-02-10 |
| Device Publish Date | 2016-04-04 |
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 [The Sequel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THE SEQUEL 75891727 not registered Dead/Abandoned |
Kajero, LLC 2000-01-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.