TPLC - Total Product Life Cycle

Device	collector, urine, (and accessories) for indwelling catheter
Regulation Description	Urine collector and accessories.
Product Code	KNX
Regulation Number	876.5250
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABCO DEALERS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIERSDORF
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BRISTOL-MYERS SQUIBB
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	3
COLOPLAST MANUFACTURING US LLC
	SUBSTANTIALLY EQUIVALENT	5
E-Z-EM, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOLLISTER, INC.
	SUBSTANTIALLY EQUIVALENT	4
INAMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SUBSTANTIALLY EQUIVALENT	12
MAERSK MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	4
NEOTECH PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
POST MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SAGE PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
SIMPORT PLASTICS LTD
	SUBSTANTIALLY EQUIVALENT	1
SNYDER LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
WELCON, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Blockage within device or device component	6
Tear, rip or hole in device packaging	2
No Known Device Problem	1
Material separation	1
Device damaged prior to use	1
Total Device Problems	11