The following data is part of a premarket notification filed by Xeridiem (formerly Mri) with the FDA for Endo Vive 3s Low Profile Balloon Kit, Endo Vive 3s Bolus Extension Sets, Endo Vive 3s Continuous Extension Sets, Endo Vive 3s Medication Extension Set.
| Device ID | K142297 |
| 510k Number | K142297 |
| Device Name: | Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | XERIDIEM (FORMERLY MRI) 4700 S. OVERLAND DR. Tucson, AZ 85714 |
| Contact | Jesus Valencia |
| Correspondent | Jesus Valencia XERIDIEM (FORMERLY MRI) 4700 S. OVERLAND DR. Tucson, AZ 85714 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-08-18 |
| Decision Date | 2015-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10813939024972 | K142297 | 000 |