FDA UDI
Not in Commercial Distribution
🇺🇸 United States
inFlow Intraurethral Valve-Pump
DI: 08625630003034
·
Model: Sep 2016
·
VESIFLO INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- inFlow Intraurethral Valve-Pump
- Primary DI
- 08625630003034
- Version / Model
- Sep 2016
- Catalog Number
- 203511 SD
- Company Name
- VESIFLO INC
- Labeler DUNS
- 005928578
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-07
- Public Version
- 4
- Public Version Date
- 2021-09-02
- Public Version Status
- Update
- Public Device Record Key
- 45167e45-2825-4447-80e2-5d7cedfe9386
- Distribution End Date
- 2021-09-01
Device Description
Urinary prosthesis, female, non-surgical -- Sizing Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PIH | Urethral Insert With Pump For Bladder Drainage | Gastroenterology, Urology | 876.5140 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62305 | Intraurethral valve/pump | A sterile, non-powered device intended to be inserted into the female urethra to facilitate urine voiding in patients with incomplete bladder emptying due to impaired detrusor contractility (IDC) of neurologic origin. It is a tube, held in place at the bladder neck, containing a pump and valve. Its function as a pump to achieve urinary voiding, and as a valve to prevent urine leakage (incontinence) between voids, is controlled by a battery-powered, magnetically-coupled remote control. This is a single-patient device intended to be left in situ for up to 29 days before being discarded (single-use) and replaced. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08625630003034 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN130044 | 000 |