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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 37 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4003136	FDA UDI	Class II	Active
Custom Procedure Kit	4000411	FDA UDI	Class II	Active
Custom Procedure Kit	4000642	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-108060-0004	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-105072-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4007004	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009968	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008066	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-104091-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200754-0002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107538-0004	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-885800-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008859	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-369030-0005	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-823900-0006	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100717-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105227-0001	FDA UDI	Class I	Unknown
Endo Smartcap	100150	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-110845-0001	FDA UDI	Class I	Unknown
Scope Buddy Plus Tubing	SB-110-HU1008	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009453	FDA UDI	Class II	Active
Endogator	100130	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-499900-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006272	FDA UDI	Class II	Active
Custom Procedure Kit	4002950	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103791-0001	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008111	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010560	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100727-0001	FDA UDI	Class I	Unknown
Gasjet CO2 Delivery System	EGA-500T	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4010541	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010471	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103632-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-101276-0004	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007720	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-844500-0002	FDA UDI	Class I	Unknown
FiberFlo	93022-131	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-108042-0006	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109934-0003	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009807	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008388	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110515-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105655-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000091	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-815750-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-298000-0005	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200011-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003818	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.