| Primary Device ID | 30815112020171 |
| NIH Device Record Key | 2845c31d-8169-4381-9d47-5d333c578153 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Protocol Administration Set with Small Catheter and Retention Cuff |
| Version Model Number | 390402 |
| Catalog Number | 390402 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 609-514-2200 |
| xx@xx.xx |
| Catheter Gauge | 20 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10815112020177 [Primary] |
| GS1 | 30815112020171 [Package] Contains: 10815112020177 Package: Box [24 Units] In Commercial Distribution |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-06-30 |
| Device Publish Date | 2016-09-19 |
| 30815112020171 | Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon |
| 30815112021284 | Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon |