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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 103 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	CPKT-102632-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPKT-107686-0001	FDA UDI	Class I	Unknown
FiberFlo	93022-175	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-108396-0003	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-144	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-103862-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002582	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104027-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-914350-0001	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-100717-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003346	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008723	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4007006	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008218	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4006061	FDA UDI	Class II	Active
Custom Procedure Kit	4003948	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007335	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-103842-0001	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-200461-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
DEFENDO Air/Water/Suction and Biopsy Valve	100305	EUDAMEDFDA UDI	Class I	Active
DEFENDO Valve and Connector Kit	100310	EUDAMEDFDA UDI	Class I	Active
DEFENDO Air/Water/Suction and Biopsy Valve	100316	EUDAMEDFDA UDI	Class I	Active
DEFENDO Disposable Biopsy Valve	100301	EUDAMEDFDA UDI	Class I	Active
Scope Buddy Plus Endoscope Flushing Aid	K162128	FDA 510(k)	Class II	Active
Dsd-91(tm) Disinfector For Flexible Endoscopes	K914145	FDA 510(k)	Class II	Active
Endo Smart Bottle, Rinse And Insufflation System	K140753	FDA 510(k)	Class II	Active
Medivators 5 Minute High-Level Disinfectant	K993042	FDA 510(k)	Class II	Active
Minncare Hd	K133724	FDA 510(k)	Class II	Active
ENDOGATOR™ Hybrid Irrigation Tubing	K231418	FDA 510(k)	Class II	Active
Endo SmartCap	K223040	FDA 510(k)	Class II	Active
Advantage Plus Pass-Thru	K172677	FDA 510(k)	Class II	Active
SCOPE BUDDY PLUS Endoscope Flushing Aid	K213833	FDA 510(k)	Class II	Active
DEFENDO Bronchoscopy Suction Valve	K151522	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
AmplifEYE	K160846	FDA 510(k)	Class II	Active
Ott Disinfector For Flexible Endoscopes	K862402	FDA 510(k)	Class II	Active
Rapicide PA High-Level Disinfectant Test Strips	K152394	FDA 510(k)	Class II	Active
DEFENDO Disposable Biopsy Valve	100302	EUDAMEDFDA UDI	Class I	Active
DEFENDO Air/Water and Suction Valves	100306	EUDAMEDFDA UDI	Class I	Active
DEFENDO Air/Water and Suction Valves	100317	EUDAMEDFDA UDI	Class I	Active
Defendo Single Use Valve Kit	4003280	EUDAMEDFDA UDI	Class I	Active
Defendo Single Use Valve Kit	100313	EUDAMEDFDA UDI	Class I	Active
DEFENDO Biopsy Valve Irrigator	100303	EUDAMEDFDA UDI	Class I	Active
Defendo Single Use Valve Kit	4000096	EUDAMEDFDA UDI	Class I	Active
Defendo	100336	EUDAMEDFDA UDI	Class I	Active
Defendo	100331	EUDAMEDFDA UDI	Class I	Active
DEFENDO Valve and Connector Kit	100315	EUDAMEDFDA UDI	Class I	Active
Defendo Single Use Valve Kit	100312	EUDAMEDFDA UDI	Class I	Active
Defendo Single Use Valve Kit	100322	EUDAMEDFDA UDI	Class I	Active
Defendo	100330	EUDAMEDFDA UDI	Class I	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.