| Primary Device ID | 00816396020818 |
| NIH Device Record Key | 58a1f1ed-40be-4091-a724-b3eaab21868d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UPMM |
| Version Model Number | 3078-00-15 |
| Catalog Number | 3078-00-15 |
| Company DUNS | 109132019 |
| Company Name | IVY BIOMEDICAL SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Phone | 203-481-4183 |
| sales@ivybiomedical.com | |
| Phone | 203-481-4183 |
| sales@ivybiomedical.com | |
| Phone | 203-481-4183 |
| sales@ivybiomedical.com |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Height | 2.5 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816396020818 [Primary] |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-14 |
| 00816396022164 | Cardiac Gating Module |
| 00816396022157 | Cardiac Gating Module |
| 00816396020825 | Cardiac Gating Module & Accessory Kit |
| 00816396020818 | Cardiac Gating Module & Accessory Kit |