| Primary Device ID | 08625630003034 |
| NIH Device Record Key | 45167e45-2825-4447-80e2-5d7cedfe9386 |
| Commercial Distribution Discontinuation | 2021-09-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | inFlow Intraurethral Valve-Pump |
| Version Model Number | Sep 2016 |
| Catalog Number | 203511 SD |
| Company DUNS | 005928578 |
| Company Name | VESIFLO INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08625630003034 [Primary] |
| PIH | Urethral Insert With Pump For Bladder Drainage |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[08625630003034]
Radiation Sterilization
[08625630003034]
Radiation Sterilization
[08625630003034]
Radiation Sterilization
[08625630003034]
Radiation Sterilization
[08625630003034]
Radiation Sterilization
[08625630003034]
Radiation Sterilization
[08625630003034]
Radiation Sterilization
[08625630003034]
Radiation Sterilization
[08625630003034]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-09-02 |
| Device Publish Date | 2016-12-07 |
| 08625630003027 | Urinary prosthesis, female, non-surgical |
| 08625630003002 | Urinary prosthesis, female, non-surgical |
| 08625630003034 | Urinary prosthesis, female, non-surgical -- Sizing Device |
| 08625630003003 | Urinary prosthesis, female, non-surgical -- Sizing Device |