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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 30 of 104

Device	Model / Reference	Registries	Class	Status
Renaflo II Hemofilter	HF 1200	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009874	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007896	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010382	FDA UDI	Class II	Active
Custom Procedure Kit	4000057	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006525	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105304-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101968	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009225	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008129	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009208	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-129480-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-982000-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000583	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009980	FDA UDI	Class II	Active
Endo Carry-On Custom Procedure Kit	4005772	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPKT-108999-0003	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Preclean Kit	4000898	FDA UDI	Class II	Active
Endo SmartCap	100164CO2EXT	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102688-0007	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001030	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110619-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001287	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000871	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002533	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000633	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001011	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009920	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-200192-0005	FDA UDI	Class I	Unknown
Double Ended Stubby Brush Single	4002610	FDA UDI	Class I	Active
Trial Procedure Kit	CPKT-108140-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009141	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-305025-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4004338	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009930	FDA UDI	Class II	Active
Custom Procedure Kit	4004416	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-103773-0008	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107425-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103128-0001	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-106590-0003	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-460800-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-891800-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101852	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-911525-0001	FDA UDI	Class II	Active
Endo Carry-On Custom Procedure Kit	4005755	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.