| Primary Device ID | 30815112020980 |
| NIH Device Record Key | e454f9cc-6ac4-4af4-a0c2-a6e6ee679677 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Super XL Enema System |
| Version Model Number | 901203 |
| Catalog Number | 901203 |
| Company DUNS | 849234661 |
| Company Name | BRACCO DIAGNOSTICS INC |
| Device Count | 1 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 609-524-2873 |
| xx@xx.xx |
| Catheter Gauge | 48 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10815112020986 [Primary] |
| GS1 | 30815112020980 [Package] Contains: 10815112020986 Package: Box [24 Units] In Commercial Distribution |
| FGD | Catheter, Retention, Barium Enema With Bag |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-06-30 |
| Device Publish Date | 2016-09-19 |
| 30815112021390 - CardioGen-82 Infusion System Model 1700 | 2023-12-11 Infusion system for Rubidium-82 saline injection. |
| 30815112021352 - CardioGen Patient Administration Set | 2023-10-24 Patient Administration Set for use with CardioGen-82 Infusion System |
| 30815112021369 - Vented Cap for Waste Bottle | 2023-10-24 Vented Cap for Waste Bottle for use with CardioGen-82 Infusion System |
| 30815112021376 - Waste Bottle | 2023-10-24 Waste Bottle for use with CardioGen-82 Infusion System |
| 30815112021239 - Protocol Touch Colon Insufflator | 2023-09-08 Protocol Touch Colon Insufflator |
| 30815112021253 - DIN 477 High Pressure Hose for CO2 | 2023-09-08 DIN Connector |
| 30815112021291 - High Pressure Hose and Yoke | 2023-09-08 High Pressure Hose and Yoke |
| 10815112020016 - Fluid Administration Set | 2023-07-28 Large Bore Tubing Administration Set |