| Primary Device ID | 00815112021214 |
| NIH Device Record Key | b662c93d-f75c-4436-bd66-b34347c9fad4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blue Air Bulb Insufflator |
| Version Model Number | 900404 |
| Catalog Number | 900404 |
| Company DUNS | 849234661 |
| Company Name | BRACCO DIAGNOSTICS INC |
| Device Count | 12 |
| 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 | |
| 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 | 00815112021214 [Unit of Use] |
| GS1 | 10815112021211 [Primary] |
| GS1 | 30815112021215 [Package] Contains: 10815112021211 Package: Box [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 | 2023-06-02 |
| Device Publish Date | 2023-05-25 |
| 10815112020870 | Air Bulb Insufflator |
| 00815112021214 | Air Bulb Insufflator |