DEVICE: Activator (00862563003153)
Device Identifier (DI) Information
Activator
August 2021
In Commercial Distribution
403300
VESIFLO INC
August 2021
In Commercial Distribution
403300
VESIFLO INC
Magnetic remote control for the inFlow Device
Device Characteristics
MR Unsafe | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PIH | Urethral Insert With Pump For Bladder Drainage |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
DEN130044 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
fae15ece-a864-4deb-9dd3-817f5e2dbf89
September 06, 2021
1
August 28, 2021
September 06, 2021
1
August 28, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined