| Primary Device ID | 00899054002357 |
| NIH Device Record Key | b6ea8b37-d9ba-4257-9c70-b483da2aabb5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SVR System without Patch |
| Version Model Number | SVC-0110S |
| Company DUNS | 791048924 |
| Company Name | KDL MEDICAL, INC. |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00899054002357 [Primary] |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2017-05-23 |
| 00899054002395 | SVR System with 150cc Mannequin™ without Patch |
| 00899054002388 | SVR System with 140cc Mannequin™ without Patch |
| 00899054002371 | SVR System with 130cc Mannequin™ without Patch |
| 00899054002364 | SVR System with 120cc Mannequin™ without Patch |
| 00899054002357 | SVR System with 110cc Mannequin™ without Patch |
| 00899054002340 | SVR System with 100cc Mannequin™ without Patch |
| 00899054002333 | SVR System with 90cc Mannequin™ without Patch |
| 00899054002326 | SVR System with 85cc Mannequin™ without Patch |
| 00899054002166 | SVR System with 80cc Mannequin™ without Patch |