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 93 of 104

Device	Model / Reference	Registries	Class	Status
Endo-Carry-on Procedure Kit	4007336	FDA UDI	Class II	Active
Custom Procedure Kit	4000831	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103352-0005	FDA UDI	Class I	Unknown
Endo Carry-On Custom Procedure Kit	4005774	FDA UDI	Class II	Active
Custom Procedure Kit	4002625	FDA UDI	Class II	Active
Custom Procedure Kit	4004550	FDA UDI	Class II	Active
Rapicide Pa Part B 3x5	ML02-PTB23	FDA UDI	Class II	Unknown
FiberFlo	93250-099	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-470015-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200234-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104854-0009	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-606600-0004	FDA UDI	Class I	Unknown
Flat Sponge	100904	FDA UDI	Class I	Active
Endo Carry-On Procedure Kit	CPK-205390-0007	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100684-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-328500-0002	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-200487-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007494	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008304	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007799	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100699-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104604-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009888	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009789	FDA UDI	Class II	Active
Essential Kit	4001135	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106841-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003091	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-107464-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104299-0001	FDA UDI	Class II	Active
FiberFlo	93022-111	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4007783	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-480875-0001	FDA UDI	Class II	Active
Cer-2	CER-2	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4010390	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-827100-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008367	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-104027-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-101223-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-395998-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200427-0006	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000577	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000227	FDA UDI	Class II	Active
Preclean Kit	4002040	FDA UDI	Class II	Active
FiberFlo	93250-029	FDA UDI	Class II	Unknown
Essential Kit	4000937	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008617	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006537	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009996	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.