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MEDIVATORS INC.

United States·US-MF-000043422

Last updated September 17, 2026

Information

Country: United States
Address: 3150, Pollok Dr, Conroe, United States
Website: www.steris.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)444-4729
PRRC Contact: Zeeshan Shamim
EUDAMED SRN: US-MF-000043422
FDA FEI Number: 3003012447
DUNS Number: 068199363

Catalogue (5153)

Page 2 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4005628	FDA UDI	Class II	Active
Custom Procedure Kit	4003319	FDA UDI	Class II	Active
Custom Procedure Kit	4003106	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Renasol Liquid Bicarbonate Concentrate	BC-1-L	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-104531-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009035	FDA UDI	Class II	Active
Custom Procedure Kit	4001077	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009969	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-491013-0008	FDA UDI	Class I	Unknown
Endo SmartCap	100164CO2	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-110585-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009194	FDA UDI	Class II	Active
Centrisol Acid Concentrate	SB-137	FDA UDI	Class II	Unknown
Custom Procedure Kit	4001932	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004147	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102684-0004	FDA UDI	Class II	Active
FiberFlo	93250-002	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	102875	FDA UDI	Class I	Unknown
AmplifEYE	EYE-101	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-107330-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-109115-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010568	FDA UDI	Class II	Active
Custom Procedure Kit	4000368	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009464	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008391	FDA UDI	Class II	Active
Custom Procedure Kit	4001020	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-110916-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103352-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101814	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000875	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010179	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009106	FDA UDI	Class II	Active
Custom Procedure Kit	4003949	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009448	FDA UDI	Class II	Active
Custom Procedure Kit	4002919	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000262	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-920000-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100997	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100818	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-108992-0001	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-109325-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-827100-0004	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4010510	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101998	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4005968	FDA UDI	Class II	Active
Essential Kit	4000922	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100680-0002	FDA UDI	Class I	Unknown

Related Companies

Authorised Representatives

STERIS Ireland Ltd IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (9)

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
Apr 20, 2021	Z-1859-2021	—	terminated	The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Oct 9, 2019	Z-1775-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1777-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1774-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1773-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1776-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1772-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Oct 9, 2019	Z-1778-2020	—	terminated	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.
Aug 3, 2015	Z-2761-2015	—	terminated	Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.