| Primary Device ID | 30815112021475 |
| NIH Device Record Key | e80f98d2-4582-48d2-a32c-222d9d90b92e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Transpec Specimen Radiography Device |
| Version Model Number | 600101 |
| Catalog Number | 600101 |
| Company DUNS | 849234661 |
| Company Name | Bracco Diagnostics Inc. |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX | |
| Phone | 609-514-2200 |
| xx@XX.XX |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815112021474 [Unit of Use] |
| GS1 | 30815112021475 [Primary] |
| FMH | Container, Specimen, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-19 |
| Device Publish Date | 2026-01-09 |
| 30815112021697 - Cysto-Aid: Urine Collection Device | 2026-01-19 Urine Collection Device |
| 30815112021444 - Mixing Container | 2026-01-19 Mixing Container |
| 30815112021475 - Transpec Specimen Radiography Device | 2026-01-19Transpec Specimen Radiography Device |
| 30815112021475 - Transpec Specimen Radiography Device | 2026-01-19 Transpec Specimen Radiography Device |
| 30815112021482 - Transpec | 2026-01-19 Transpec Specimen Radiography Device |
| 30815112021505 - E-Z-Mark | 2026-01-19 Marker |
| 30815112021543 - HeartSee Cardiac PET Processing Software | 2025-08-04 Cardiac PET Processing Software |
| 30815112021703 - Two Tank Shuttle Valve System | 2025-07-08 Two Tank Shuttle Valve System |
| 30815112021710 - DIN 477 High Pressure Hose for CO2 | 2025-07-08 DIN Connector |