| Primary Device ID | 30815112021659 |
| NIH Device Record Key | f638a8b6-b945-431b-b161-5aea793e3c67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLEXI-STOME Cone Colostomy Tip |
| Version Model Number | 901306 |
| Catalog Number | 901306 |
| 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 | 609-514-2200 |
| 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 | 10815112021655 [Primary] |
| GS1 | 30815112021659 [Package] Contains: 10815112021655 Package: [12 Units] In Commercial Distribution |
| FGD | Catheter, Retention, Barium Enema With Bag |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-09 |
| Device Publish Date | 2025-05-30 |
| 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 |