Is this your brand? Sign in to claim ownership.

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 13 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4000543	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008814	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-916500-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200510-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101973	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003930	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007488	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103773-0005	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100995	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100956	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003951	FDA UDI	Class II	Active
Custom Procedure Kit	4001910	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000247	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104323-0001	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-353	FDA UDI	Class II	Active
Custom Procedure Kit	4001440	FDA UDI	Class II	Active
Custom Procedure Kit	4000270	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010380	FDA UDI	Class II	Active
Custom Procedure Kit	4000604	FDA UDI	Class II	Active
FiberFlo	93023-151	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4006192	FDA UDI	Class II	Active
Endo Carry-On Custom Procedure Kit	4005753	FDA UDI	Class II	Active
Preclean Kit	4001126	FDA UDI	Class II	Active
Custom Procedure Kit	4003414	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102138-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000823	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4000145	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000645	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-982000-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-110565-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009511	FDA UDI	Class II	Active
Endo Smartcap	100141	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102292-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-111289-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-108042-0005	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107245-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4007007	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-885000-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100827	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100838	FDA UDI	Class I	Unknown
Advantage Plus Endoscope Reprocessing System	1-2-510.003	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4002756	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4000549	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.