| Primary Device ID | 10815112020016 |
| NIH Device Record Key | 471ea654-56d6-4225-8e72-10857d7f6f45 |
| Commercial Distribution Discontinuation | 2023-07-27 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Fluid Administration Set |
| Version Model Number | 000475 |
| Catalog Number | 000475 |
| Company DUNS | 849234661 |
| Company Name | BRACCO DIAGNOSTICS 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 | false |
| Manufacturing Date | false |
| 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 |
| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Phone | 6095142200 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10815112020016 [Primary] |
| GS1 | 20815112020013 [Package] Package: Box [10 Units] Discontinued: 2023-07-27 Not in Commercial Distribution |
| GS1 | 30815115050010 [Package] Package: Box [80 Units] Discontinued: 2023-07-27 Not in Commercial Distribution |
| EYN | Tray, Irrigation, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-07-28 |
| 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 | 2023-07-28Large Bore Tubing Administration Set |
| 10815112020016 - Fluid Administration Set | 2023-07-28 Large Bore Tubing Administration Set |