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Found 10 results
510(k) Data Aggregation
K Number
K110518Device Name
IBAG
Manufacturer
FUTURE PATH MEDICAL, LLC
Date Cleared
2011-06-24
(121 days)
Product Code
KNX, EXS
Regulation Number
876.5250Why did this record match?
Product Code :
KNX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to measure/ display collected urine volume. It detects fill level and temperature.
Device Description
iBag™ is a urine management system that includes bladder and temperature measurement for catheterized patients who desire to be fully mobile. · iBag™ provides accurate, real-time assistive data. It does this through use of a calibrated drainage bag integrated with a Future Path Medical sensor, a base transmitter unit called Wi-Mitter™ for wireless transmission of urine bag fill and bladder temperature information. Once the Wi-Mitter™ is snapped in place, the container is polled and the measurement of fluid level begins and this data is then transmitted to the patient, the care provider (an aid) a family member, or even to the hospital's base station. Data is transmitted via traditional data networking and may be interpreted and displayed on a user's laptop computer, and other types monitors. Since the data from the Wi-Mitter™ is time and date stamped, time of fill level may be automatically calculated, noted and threshold values used for fill level alarming.
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K Number
K973364Device Name
4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
Manufacturer
MAERSK MEDICAL A/S
Date Cleared
1998-03-17
(190 days)
Product Code
KNX
Regulation Number
876.5250Why did this record match?
Product Code :
KNX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The basics of the intended use has not changed. The Maersk Medical 4L drainage bag continue to be intended for collection of fluid which is on its way away from the body. The 4L drainage bag can be used in different treatment procedures within areas as urology and dialysis, but in any case the intended use is the same. The device label will state the following: A: "Peritoned Dialysis Drainage bag" B: "Collection bag fer urine"
Device Description
The general description, operation, construction and use of the Maersk Medical 4L drainage bag has not changed as a result of the modifications. The 4L drainage bag contains basically the same features as the device described in K843480 and the manufacturing process is identical. However the 4L drainage bags will hold 4000 ml. compared to 2000 ml. for the device described in K843480. On a few points features has been added to the 4L drainage bag, but they are all added to improve patient and healthcare personnel comfort.
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K Number
K972887Device Name
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
Manufacturer
MEDLINE INDUSTRIES, INC.
Date Cleared
1997-12-11
(128 days)
Product Code
KNX
Regulation Number
876.5250Why did this record match?
Product Code :
KNX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These devices are indicated for use by incontinent persons with other medical conditions that warrant the use of a leg bag and are intended to collect urine. They may be connected to either an indwelling or non-indwelling catheter.
Device Description
Medline Leo Bags are vinyl pouches with sterile fluid paths and adjustable comfort straps. This device is attached to the leg of an incontinent person and used to collect urine. This device may be used with an indwelling catheter or an external catheter. A leg bag provides the catheterized person with greater mobility and are usually worn during the day and are replaced at night with a standard urinary drainage bag.
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K Number
K971271Device Name
BESECURE EXTERNAL URINARY COLLECTION SYSTEM
Manufacturer
UROLOGY RESEARCH INTL., INC.
Date Cleared
1997-08-18
(136 days)
Product Code
KNX
Regulation Number
876.5250Why did this record match?
Product Code :
KNX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BeSECURE External Urinary Collection System is an external urine collection system for the incontinent patient.
Device Description
Not Found
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K Number
K971929Device Name
AMSINO URINARY LEG BAG
Manufacturer
AMSINO INTL., INC.
Date Cleared
1997-08-06
(71 days)
Product Code
KNX
Regulation Number
876.5250Why did this record match?
Product Code :
KNX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Amsino Urinary Leg Bag is a device intended to collect urine.
Device Description
Not Found
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K Number
K971764Device Name
WELCON HUE-VU URINARY DRAINAGE BAG
Manufacturer
WELCON, INC.
Date Cleared
1997-07-29
(77 days)
Product Code
KNX
Regulation Number
876.5250Why did this record match?
Product Code :
KNX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Welcon Hue-Vu™ Urinary drainage Bag is indicated for use for the collection of urine when used with an indwelling catheter.
Device Description
The Welcon Hue-Vu™ Urinary Drainage Bag is a 2000 ml capacity vented vinyl urine collection receptacle intended to be used with an indwelling catheter. The bag has a hanging hook at the top, and is equipped with a sampling port near the catheter connector. The inlet tubing has an anti-reflux valve to prevent backflow. A vent allows air to escape the bag as urine enters. A Hue-Vu™ color strip label is affixed to the front of the bag, and is used to compare and record the color of the urine collected in the bag.
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K Number
K964690Device Name
LIBERTY VALVE
Manufacturer
CLEVELAND MEDICAL DEVICES, INC.
Date Cleared
1997-03-21
(119 days)
Product Code
KNX
Regulation Number
876.5250Why did this record match?
Product Code :
KNX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Liberty Valve is intended to allow individuals in a wheelchair to empty their own urine collection leg bag, which may be connected to either an indwelling or non-indwelling catheter, provided the individual possesses the ability to make gross arm and hand movements.
Device Description
The Liberty Valve consists of a switch box, a solenoid valve with electrical connection, a fuse, battery leads with wiring, and tubing with the necessary connections for attachment to the leg bag and valve. The device is to be mounted to the wheelchair permanently with the clamps and wire ties provided. The switch box regulates the power from the battery which opens the solenoid valve the urine collection leg bag to drain.
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K Number
K964745Device Name
AMSINO URINARY DRAINAGE BAG
Manufacturer
AMSINO INTL., INC.
Date Cleared
1997-03-18
(112 days)
Product Code
KNX
Regulation Number
876.5250Why did this record match?
Product Code :
KNX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K962652Device Name
URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
Manufacturer
CUSTOMED, INC.
Date Cleared
1996-10-04
(88 days)
Product Code
KNX
Regulation Number
876.5250Why did this record match?
Product Code :
KNX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960949Device Name
PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167
Manufacturer
BRISTOL-MYERS SQUIBB
Date Cleared
1996-04-19
(39 days)
Product Code
KNX
Regulation Number
876.5250Why did this record match?
Product Code :
KNX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
indicated for use in the collection of free flowing urinary drainage.
Device Description
ProSys™ Bedside Drainage Bag (Sterile) is available with a 2000 ml volume capacity. Each stèrile bag is fitted with a permanently welded 55 inch inlet tube containing a universal connector which connects to an indwelling or external catheter. The Bedside Drainage Bag (Sterile) has a T-tap drainage valve. The inlet tube contains an anti-reflux valve to reduce the risk of urine backflow and infection and, a sample port used for urine sampling is integrated into the universal connecter.
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