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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 20 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4003213	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009111	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006124	FDA UDI	Class II	Active
Custom Procedure Kit	4002334	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010310	FDA UDI	Class II	Active
Endogator Kit	4005472	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	4001140	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009904	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-645311-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108013-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4006117	FDA UDI	Class II	Active
Pentax Endo Smartcap	100551P	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	4001138	FDA UDI	Class II	Active
Custom Procedure Kit	4000673	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-100680-0005	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-982000-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-200461-0004	FDA UDI	Class II	Active
ENDOGATOR Kit	100651	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009435	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200625-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009354	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107686-0001	FDA UDI	Class II	Active
FiberFlo	93022-051	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4007697	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008900	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107519-0004	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000105	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105350-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010645	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007888	FDA UDI	Class II	Active
FiberFlo	93250-204	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-111224-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101367-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000364	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104854-0013	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010456	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101512-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106106-0001	FDA UDI	Class I	Unknown
Renasol Acid Concentrate	SB-1014	FDA UDI	Class II	Active
Custom Procedure Kit	4000988	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001844	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009217	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007942	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106842-0003	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4006202	FDA UDI	Class II	Active

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.