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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 29 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	CPK-108327-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108671-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003646	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101972	FDA UDI	Class I	Unknown
Endogator	100116	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100774-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103436-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-103998-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103773-0014	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009152	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010173	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010403	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108309-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007707	FDA UDI	Class II	Active
Custom Procedure Kit	4002992	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010519	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006517	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104232-0011	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101864	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-238500-0005	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-480875-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008168	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009191	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010585	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-104195-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001906	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006286	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107989-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003815	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101948	FDA UDI	Class II	Active
Mini Pull Thru W/ Stubby Combo	4002600	FDA UDI	Class I	Active
Trial Procedure Kit	CPKT-104623-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-834500-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104848-0001	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4001101	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105701-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104187-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-111076-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4007217	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007406	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-914700-0007	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009043	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008845	FDA UDI	Class II	Active
Rapicide Glutaraldehyde Indicator Test Strips	ML02-0120	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104614-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4001132	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.