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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 82 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	CPKT-109519-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101852-0001	FDA UDI	Class II	Active
Custom Procedure Kit	4002860	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101849	FDA UDI	Class I	Unknown
Minncare HD 1% Indicator Test Strips	3029796	FDA UDI	Class II	Active
Custom Procedure Kit	4005093	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008162	FDA UDI	Class II	Active
Preclean Kit	4001128	FDA UDI	Class II	Active
Custom Procedure Kit	4000160	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104259-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003076	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104163-0002	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007230	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-441700-0003	FDA UDI	Class II	Active
Custom Procedure Kit	4000220	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009436	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009226	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4010528	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103731-0001	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008019	FDA UDI	Class II	Active
Custom Procedure Kit	4001847	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002684	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102866	FDA UDI	Class I	Unknown
Pentax Irrigation Tubing	100125P	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4010469	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4003033	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-106546-0001	FDA UDI	Class I	Unknown
Renaflo II Hemofilter	HF 400	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-105519-0003	FDA UDI	Class II	Active
Custom Procedure Kit	4000980	FDA UDI	Class II	Active
Custom Procedure Kit	4005066	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-107326-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000056	FDA UDI	Class II	Active
Custom Procedure Kit	4000672	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010389	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200432-0002	FDA UDI	Class II	Active
FiberFlo	93023-142	FDA UDI	Class II	Unknown
Custom Procedure Kit	4002639	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101048-0009-33	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108191-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008143	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009046	FDA UDI	Class II	Active
Centrisol Acid Concentrate	SB-343	FDA UDI	Class II	Unknown
Custom Procedure Kit	4002637	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-109380-0001	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.