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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 40 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4001843	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009999	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-100080-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107334-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-107194-0001	FDA UDI	Class I	Unknown
Pull Thru 4.8mm Cassette Refill (180x12)	4002598	FDA UDI	Class I	Active
Endo-Carry-on Procedure Kit	4006231	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-974920-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103773-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102874	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-164	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-200427-0002	FDA UDI	Class I	Unknown
FiberFlo	93250-142	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-110255-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-101215-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-660000-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100215-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006148	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008167	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-916660-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-109006-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008393	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009243	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009413	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101846	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108349-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102880	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009699	FDA UDI	Class II	Active
ENDOGATOR hybrid irrigation tubing	100605	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010527	FDA UDI	Class II	Active
Custom Procedure Kit	4004568	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009861	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101865	FDA UDI	Class I	Unknown
FiberFlo	93250-194	FDA UDI	Class II	Unknown
Essential Kit	4000913	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007481	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008836	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103855-0002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	103884	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104757-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009726	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008360	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100826	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008528	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100983	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.