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510(k) Data Aggregation
K Number
K971499Device Name
FEMALE EXTERNAL URINARY COLLECTION POUCH
Manufacturer
MEDIQUEST, INC.
Date Cleared
1997-08-28
(125 days)
Product Code
EXI
Regulation Number
876.5250Why did this record match?
Product Code :
EXI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a disposable, single use Female External Urinary Collection Pouch, it is intended to collect urine and assist in directing it away from the body.
Device Description
Mediquest, Inc.'s Female External Urinary Collection Pouch
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K Number
K970443Device Name
HOLLISTER RETRACTED PENIS POUCH
Manufacturer
HOLLISTER, INC.
Date Cleared
1997-02-25
(20 days)
Product Code
EXI
Regulation Number
876.5250Why did this record match?
Product Code :
EXI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
to collect urine from incontinent men by encompassing the penis
Device Description
The Hollister Urine Collection Pouch is a one-piece disposable system which collects urine by encompassing the penis. The pouch is made from odor-barrier film and features a synthetic skin barrier adhesive which aids in the protection of the skin. If required the precut opening in the barrier may be enlarged to accommodate the anatomy of the user. Strips of adhesive microporous tape may be used for additional security.
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K Number
K963950Device Name
BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
Manufacturer
BIODERM, INC.
Date Cleared
1997-01-10
(100 days)
Product Code
EXI
Regulation Number
876.5250Why did this record match?
Product Code :
EXI
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.
Device Description
BioDerm® EID® MALE EXTERNAL INCONTINENCE DEVICE
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