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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 64 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-on Procedure Kit	4009446	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009304	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009871	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103436-0003	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010637	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4001459	FDA UDI	Class II	Active
Custom Procedure Kit	4000347	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-136950-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008800	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104358-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200842-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104241-0002	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-101367-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000424	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200306-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-110120-0003	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4000585	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002689	FDA UDI	Class II	Active
Custom Procedure Kit	4000367	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-539060-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003137	FDA UDI	Class II	Active
Pull Thru Channel Cleaning Brush Single	4002592	FDA UDI	Class I	Active
FiberFlo	93023-141	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-101367-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003341	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007833	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009155	FDA UDI	Class II	Active
Essential Kit	4000944	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009347	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008036	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	101840	FDA UDI	Class I	Unknown
Pull Thru	Channel Brush	FDA UDI	Class I	Active
Endo Carry-on Procedure Kit	4009170	FDA UDI	Class II	Active
Custom Procedure Kit	4001084	FDA UDI	Class I	Unknown
FiberFlo	93022-018	FDA UDI	Class II	Unknown
Custom Procedure Kit	4005680	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104344-0005	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009410	FDA UDI	Class II	Active
Endogator Irrigation Pump	EGP-100	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101807	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100962-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101836	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102918	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.