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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 22 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	101885	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109325-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-914700-0001	FDA UDI	Class I	Unknown
Scope Buddy Plus Tubing	SB-110-HU1007	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007871	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101999	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009465	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-920000-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101994	FDA UDI	Class I	Unknown
Pull Thru Cassette Refill (240x12)	4002597	FDA UDI	Class I	Active
Endo Carry-On Procedure Kit	CPK-107493-0003	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009438	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-107462-0005	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009884	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009094	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009241	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009173	FDA UDI	Class II	Active
Pentax Irrigation Pump	EGP-100P	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101276-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-328400-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102659-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-785600-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003089	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-562000-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-616590-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102845	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006152	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010024	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009598	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-305025-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000787	FDA UDI	Class II	Active
Cleanascope Essential Kit	4002042	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-102659-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007484	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-110450-0005	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-103773-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008372	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009353	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105072-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103409-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-104191-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107516-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103773-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010400	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-108042-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003968	FDA UDI	Class II	Active
Custom Procedure Kit	4005103	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009415	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.