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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 50 of 104

Device	Model / Reference	Registries	Class	Status
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200843-0005	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108112-0002	FDA UDI	Class II	Active
FiberFlo	93250-180	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-663055-0002	FDA UDI	Class I	Unknown
Preclean Kit	4001124	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010592	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010051	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-867500-0003-33	FDA UDI	Class I	Unknown
Pentax Endo Smartcap	100150CO2P	FDA UDI	Class II	Unknown
Custom Procedure Kit	4004347	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006260	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008754	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-106217-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100802	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4009011	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107679-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100967	FDA UDI	Class II	Active
FiberFlo	93250-182	FDA UDI	Class II	Unknown
Preclean Kit	4000910	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010459	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006519	FDA UDI	Class II	Active
Endogator	100241	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4000102	FDA UDI	Class II	Active
Endo Carry-on Custom Procedure Kit	4005883	FDA UDI	Class II	Active
Custom Procedure Kit	4001463	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104822-0001	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
ENDOGATOR Kit	100618	FDA UDI	Class II	Active
Custom Procedure Kit	4003011	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009122	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-101241-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010269	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009825	FDA UDI	Class II	Active
Custom Procedure Kit	4002631	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-100381-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-606051-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010672	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010531	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-597000-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-107404-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-914045-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108538-0001	FDA UDI	Class II	Active
Custom Procedure Kit	4000120	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007701	FDA UDI	Class II	Active
Custom Procedure Kit	4002479	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009771	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.