| Primary Device ID | 00850005470649 |
| NIH Device Record Key | 4e23e8e4-f3c0-43b9-927e-2753651a0f36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SherpaPak Cardiac Transport System (CTS) |
| Version Model Number | SHRP-1001-002 |
| Company DUNS | 961780660 |
| Company Name | Paragonix Technologies 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| 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 | 00850005470649 [Primary] |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-13 |
| Device Publish Date | 2025-05-05 |
| 00850005470649 - SherpaPak Cardiac Transport System (CTS) | 2025-05-133C SherpaCool Ribbons |
| 00850005470649 - SherpaPak Cardiac Transport System (CTS) | 2025-05-13 3C SherpaCool Ribbons |
| 00850005470632 - KidneyVault | 2025-03-05 KidneyVault Cannula Multi-Pack (3, 5, 7, 9, 7x20, 10x35) |
| 00850005470359 - KidneyVault | 2024-12-03 KidneyVault Shipper |
| 00850005470373 - KidneyVault | 2024-12-03 KidneyVault Canister |
| 00850005470588 - KidneyVault | 2024-12-03 KidneyVault Cannula Multipack )3mm, 5mm, 7mm, 9mm, 7x20mm) |
| 00850005470595 - KidneyVault | 2024-12-03 KidneyVault SherpaCool |
| 10850005470035 - PancreasPak | 2024-09-09 PancreasPak Shipper Base |
| 00850005470618 - PancreasPak | 2024-09-09 PancreasPak SherpaCool |