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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 99 of 104

Device	Model / Reference	Registries	Class	Status
Endo-Carry-on Procedure Kit	4007855	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007485	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008128	FDA UDI	Class II	Active
Custom Procedure Kit	4002511	FDA UDI	Class I	Unknown
Essential Kit	4000938	FDA UDI	Class II	Active
Custom Procedure Kit	4005634	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008018	FDA UDI	Class II	Active
Custom Procedure Kit	4010518	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-105880-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010304	FDA UDI	Class II	Active
FiberFlo	93022-023	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-303100-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPKT-205350-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004390	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101215-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105352-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-759000-0003	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007354	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-583050-0005	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-111564-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108349-0007	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000977	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009118	FDA UDI	Class II	Active
Custom Procedure Kit	4000182	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102911	FDA UDI	Class I	Unknown
Custom Procedure Kit	4005749	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007698	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-104641-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-101048-0010-33	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-104232-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102925	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-251200-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104641-0003	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
FiberFlo	93022-052	FDA UDI	Class II	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	101801	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-129480-0001	FDA UDI	Class I	Unknown
Preclean Kit	4000911	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-736500-0006	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008731	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110487-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102905	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103539-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-111366-0002	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-152	FDA UDI	Class II	Unknown
Custom Procedure Kit	4002561	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4008521	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-599500-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102612-0001	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.