DEVICE: inFlow Intraurethral Valve-Pump (08625630003002)

Device Identifier (DI) Information

inFlow Intraurethral Valve-Pump
Sep 2016
Not in Commercial Distribution
203511
VESIFLO INC
08625630003002
GS1
December 31, 2020
1
005928578 *Terms of Use
Urinary prosthesis, female, non-surgical
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Device Characteristics

MR Unsafe
No
Yes
Yes
Yes
No
No
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
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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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
Length: 60 Millimeter
Length: 55 Millimeter
Length: 50 Millimeter
Length: 45 Millimeter
Length: 40 Millimeter
Length: 35 Millimeter
Length: 30 Millimeter
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Device Record Status

61b658fc-189b-4123-a69c-9f04ce5bd678
December 31, 2020
4
September 20, 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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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