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Medisystems Corp.

Last updated May 23, 2026

Information

Country: US
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Catalogue (218)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus	S9-7437MGP	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus	S9-4007MGP	FDA UDI	Class II	Unknown
Medisystems Button Hole Needle Set	BH-7005	FDA UDI	Class II	Unknown
Medisystems Apheresis Needle Set with MasterGuard	P9-7017MG	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set	S9-5005	FDA UDI	Class II	Unknown
Medisystems TwinPack Hemodialysis Fistula Needle Set with Masterguard Plus	D9-2016MGP	FDA UDI	Class II	Unknown
Medisystems Apheresis Needle Set with MasterGuard	P9-7008MG	FDA UDI	Class II	Unknown
Medisystems TwinPack Hemodialysis Fistula Needle Set with Masterguard Plus	D9-2006MGPLB	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with MasterGuard	D9-7016MG	FDA UDI	Class II	Unknown
Medisystems TwinPack ButtonHole Needle Set with SteriPick	BH-2006PE	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Blood Tubing Sets	B3-6605M6792	FDA UDI	Class II	Unknown
Medisystems TwinPack Hemodialysis Fistula Needle Set with Masterguard Plus	D9-2015MGP	FDA UDI	Class II	Unknown
Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard	D9-2006MG	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus	S9-7007MGPLB	FDA UDI	Class II	Unknown
Medisystems TwinPack ButtonHole Needle Set with SteriPick	BH-2006PE	FDA UDI	Class II	Unknown
Medisystems OneSite dual lumen buttonhole needle with steripick	DL-2004PE	FDA UDI	Class II	Active
Medisystems Hemodialysis Fistula Needle Set with MasterGuard	S9-7007MGLB	FDA UDI	Class II	Unknown
Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard	D9-2005MGP	FDA UDI	Class II	Active
Medisystems OneSite dual lumen buttonhole needle with steripick	DL-1204PE	FDA UDI	Class II	Active
Medisystems Hemodialysis Blood Tubing Sets	B3-6604M6792	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with MasterGuard	S9-7008MG	FDA UDI	Class II	Active
Medisystems Hemodialysis Fistula Needle Set with MasterGuard	D9-4005MG	FDA UDI	Class II	Unknown
Medisystems Button Hole Needle Set	BH-7004	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus	D9-7015MGP	FDA UDI	Class II	Unknown
Medisystems Button Hole Needle Set with SteriPick	BH-4006PE	FDA UDI	Class II	Unknown
Medisystems TwinPack Hemodialysis Fistula Needle Set with Masterguard Plus	D9-2016MGP	FDA UDI	Class II	Unknown
Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard	D9-2007MG	FDA UDI	Class II	Unknown
Medisystems Button Hole Needle Set with SteriPick	BH-7035PE	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus	S9-7014MGP	FDA UDI	Class II	Unknown
Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri	SLE-3000M3095	FDA UDI	Class II	Unknown
Medisystems Apheresis Needle Set with MasterGuard	P9-7006MGLB	FDA UDI	Class II	Unknown
Medisystems Button Hole Needle Set	BH-7605	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus	D9-4005MGP	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus	S9-7006MGPLB	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with MasterGuard	D9-7006MGP	FDA UDI	Class II	Active
Streamline Airless System Set with Locksite Needleless Access Sites and SecureCl	SL-2011M2098	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus	S9-7435MGP	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with MasterGuard	D9-7004MG	FDA UDI	Class II	Unknown
Streamline Airless System Set with Locksite Needleless Access Sites	SL-2000M2095	FDA UDI	Class II	Unknown
Medisystems TwinPack Hemodialysis Fistula Needle Set with Masterguard Plus	D9-2007MGPLB	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus	D9-7006MGPLB	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with Masterguard Plus	S9-4017MGP	FDA UDI	Class II	Unknown
Medisystems Button Hole Needle Set with SteriPick	BH-7036PE	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with MasterGuard	D9-7006MG	FDA UDI	Class II	Unknown
Medisystems Hemodialysis Fistula Needle Set with MasterGuard	S9-4017MG	FDA UDI	Class II	Unknown
Medisystems Button Hole Needle Set with SteriPick	BH-7007PE	FDA UDI	Class II	Unknown
Medisystems Transducer Protector	K895856	FDA 510(k)	Class II	Active
Medisystems Tranducer Protector	K970536	FDA 510(k)	Class II	Active
Medisystems Buttonhole Needle Sets	K990803	FDA 510(k)	Class II	Active
I.v. Administration Set	K811837	FDA 510(k)	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 31, 2012	Z-1126-2012	—	terminated	Mislabeled outer carton: Outside shipping cartons is stamped 15Ga x 1", product contained within properly labeled as 17Ga x 1" needle