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510(k) Data Aggregation
K Number
K962604Device Name
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
Manufacturer
Date Cleared
1996-07-18
(16 days)
Product Code
Regulation Number
876.5250Why did this record match?
Product Code :
FAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
indicated for the management of urinary incontinence.
Device Description
ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing which is available in a volume capacity of 500ml. Each non-sterile bag is fitted with a permanently welded adjustable inlet tube with a self-packaged connector which connects to an external catheter. The inlet tube is available in one (1) size, 600mm to accommodate patient preference. Fabric straps are used to secure the leg bag in place. The leg bag 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 connector.
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K Number
K960217Device Name
CPR URINE BAG
Manufacturer
Date Cleared
1996-03-28
(72 days)
Product Code
Regulation Number
876.5250Why did this record match?
Product Code :
FAQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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