DEVICE: Activator (08625630003001)

Device Identifier (DI) Information

Activator
Sep 2016
Not in Commercial Distribution
403507
VESIFLO INC
08625630003001
GS1
December 31, 2020
1
005928578 *Terms of Use
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
PIH Urethral Insert With Pump For Bladder Drainage
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN130044 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ee0f3b62-f411-4f10-8e67-239ddf0e7aa2
December 31, 2020
4
September 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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