| Primary Device ID | B040WD202J |
| NIH Device Record Key | ff971703-9321-4d7c-b9ea-e49a88116e37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Universal Y Connector |
| Version Model Number | WD-20 |
| Company DUNS | 939872651 |
| Company Name | GENESEE BIOMEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com | |
| Phone | 800 786-4890 |
| info@geneseebiomedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B040WD201 [Primary] |
| HIBCC | B040WD202J [Package] Contains: B040WD201 Package: [1 Units] In Commercial Distribution |
| KDQ | Bottle, Collection, Vacuum |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2017-02-01 |
| B040WF26 - WellForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B040WF28 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B040WF30 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B040WF32 - WellsFormTricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B040WF34 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B040WF360 - WellsForm Tricuspid Annuloplasty Band | 2023-10-10 Annuloplasty Band |
| B0404200260 - NeoForm | 2019-05-30 Annuloplasty Ring |
| B040420028 - NeoForm | 2019-05-30 Annuloplasty Ring |