| Primary Device ID | 00815112021344 |
| NIH Device Record Key | f8225eb7-32e6-4cab-a3fa-0df95d713971 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elution Test Vial |
| Version Model Number | 001730 |
| Company DUNS | 849234661 |
| Company Name | Bracco Diagnostics Inc. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx | |
| Phone | 800-447-6883 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815112021344 [Unit of Use] |
| GS1 | 30815112021345 [Primary] |
| GS1 | 50815112021349 [Package] Contains: 30815112021345 Package: [6 Units] In Commercial Distribution |
| FRN | Pump, Infusion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-05-26 |
| Device Publish Date | 2024-02-13 |
| 00815112021535 - Junior Flexi Tip Pediatric Enema Tip | 2025-06-09 Junior Flexi Tip |
| 10815112021556 - SaftiCuff DK | 2025-06-09 Safticuff DL Airway |
| 10815112021563 - Super XL Enema System | 2025-06-09 SXL w/Att. (Silicone Cuff) |
| 30815112021581 - Enema Kit: Empty Enema Bag Delivery System | 2025-06-09 Empty Snap Cap Bag |
| 10815112021594 - EXACTA l Screw Cap Bag: Empty Enema Bag Delivery System | 2025-06-09 Empty Exacta l Bag |
| 10815112021624 - 24 Fr Infant Flexi Tip: Pediatric Enema Tip | 2025-06-09 Infant Flexi Tip |
| 30815112021635 - Miller Enema Air Tip: Without Retention Cuff | 2025-06-09 Miller Air Tip |
| 00815112021641 - 14 French Pediatric Flexi Tip | 2025-06-09 14 Fr Pediatric Flexi Tip |