| Primary Device ID | 10869582000313 |
| NIH Device Record Key | 40e2f66a-6bf0-4153-9355-fbe62b977812 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Paragonix SherpaPak Cardiac Transport System |
| Version Model Number | SHRP-1001-001 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | 00850005470267 [Package] Contains: 20869582000310 Package: Outer Box [1 Units] In Commercial Distribution |
| GS1 | 00869582000316 [Primary] |
| GS1 | 10869582000313 [Package] Contains: 00869582000316 Package: Box [1 Units] In Commercial Distribution |
| GS1 | 20869582000310 [Package] Contains: 00869582000316 Package: Inner Box [1 Units] In Commercial Distribution |
| MSB | System And Accessories, Isolated Heart, Transport And Preservation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-05-23 |
| Device Publish Date | 2019-02-15 |
| 00869582000385 | Paragonix SherpaPak Cardiac Transport System HC 32mm |
| 00869582000378 | Paragonix SherpaPak Cardiac Transport System HC 25.4mm |
| 00869582000361 | Paragonix SherpaPak Cardiac Transport System HC 18mm |
| 00869582000354 | Paragonix SherpaPak Cardiac Transport System HC 10mm |
| 00869582000347 | Paragonix SherpaPak Cardiac Transport System Ships with 4 heart connectors: 00869582000354 (10mm |
| 00869582000330 | Paragonix SherpaPak Heart Connector Box Contains 4 heart connectors: 00869582000354 (10mm x 1) 0 |
| 00869582000323 | Paragonix SherpaCool Ribbons and Pouch |
| 10869582000313 | Paragonix SherpaPak Shipper CTS |
| 10850005470271 | SherapaPak SherpaCool Ribbons and Pouch |