| Primary Device ID | 04046964188770 |
| NIH Device Record Key | e3dbdaf3-a451-434b-8407-99b03a1e708c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irrigation Set |
| Version Model Number | V4500 |
| Catalog Number | V4500 |
| Company DUNS | 002397347 |
| Company Name | B. BRAUN MEDICAL INC. |
| Device Count | 20 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)227-2862 |
| BBMUS_Service.EmailOrders@bbra |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964188763 [Unit of Use] |
| GS1 | 04046964188770 [Primary] |
| LJH | System, irrigation, urological |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-09-23 |
| 04046964368745 | Irrigation/Urology Set, Non-vented Sp ike and Distal Foley Catheter Connector |
| 04046964291487 | UniSpike™ Connector, Distal Fle xible Connector |
| 04046964291463 | Four-Bag Irrigation Set, Four Non-ven ted Spikes |
| 04046964291449 | T.U.R./Cysto Set UniSpikeTM Connector |
| 04046964291425 | SuperSet™ Four-Bottle Irrigatio n Set |
| 04046964291401 | SuperSet™ Two-Bottle Irrigation Set |
| 04046964188879 | Continuous Overhead Irrigation Set, Non-vented Spike |
| 04046964188794 | UniSpike™ Connector, Distal Fol ey Catheter Connector |
| 04046964188770 | Cysto Post-Operative Irrigation Set |
| 04046964188756 | T.U.R. Irrigation Connecting Set |
| 04046964175794 | Two-Bag Irrigation Set, Two Non-vente d Spikes |
| 04046964186950 | PIC™ Irrigation Container Spike Adaptor |