| Primary Device ID | 10815112020634 |
| NIH Device Record Key | 52535d9c-60a6-4710-ba6a-e2336dd5cb57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enema Kit: Empty Enema Bag Delivery System |
| Version Model Number | 900303 |
| Catalog Number | 900303 |
| 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 | |
| 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 | 10815112020634 [Primary] |
| GS1 | 30815112020638 [Package] Package: Box [48 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 | 2020-07-07 |
| Device Publish Date | 2020-06-29 |
| 30815112020829 | Empty Snap Cap Bag |
| 30815112020812 | Empty Snap Cap Bag |
| 10815112020634 | Empty Snap Cap Bag |
| 10815112021174 | Empty Snap Cap Bag |