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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 102 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Custom Procedure Kit	4005871	FDA UDI	Class II	Active
Custom Procedure Kit	4001900	FDA UDI	Class II	Active
Custom Procedure Kit	4004266	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007545	FDA UDI	Class II	Active
Custom Procedure Kit	4005101	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008781	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107538-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-205390-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-104759-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-107440-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-104179-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPKT-108806-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009882	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010003	FDA UDI	Class II	Active
Custom Procedure Kit	4001859	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008358	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007263	FDA UDI	Class II	Active
Preclean Kit	4000905	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009862	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008625	FDA UDI	Class II	Active
Custom Procedure Kit	4004529	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007493	FDA UDI	Class II	Active
Pentax Irrigation Pump	EGA-501P	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPKT-109519-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001012	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002534	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-233200-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008329	FDA UDI	Class II	Active
Custom Procedure Kit	4000839	FDA UDI	Class II	Active
Custom Procedure Kit	4005615	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-108396-0008	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPKT-105729-0003	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007850	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-152250-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108014-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002622	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-106693-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109934-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000144	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPKT-645311-0004	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007999	FDA UDI	Class II	Active
Custom Procedure Kit	4000421	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-136300-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008864	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100937	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100949-0001	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.