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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 100 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4001467	FDA UDI	Class II	Active
Custom Procedure Kit	4000610	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101848	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-111456-0005	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008283	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-103773-0006	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008125	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-105495-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009357	FDA UDI	Class II	Active
Custom Procedure Kit	4004548	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-103138-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-300775-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-101673-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102839	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105463-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105469-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109208-0001	FDA UDI	Class I	Unknown
FiberFlo	93250-000	FDA UDI	Class II	Unknown
Custom Procedure Kit	4005609	FDA UDI	Class II	Active
Custom Procedure Kit	4000050	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007837	FDA UDI	Class II	Active
Custom Procedure Kit	4002740	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103773-0013	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103628-0001	FDA UDI	Class I	Unknown
Endogator	100105	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-109795-0002	FDA UDI	Class II	Active
Centrisol Acid Concentrate	SB-145	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4007501	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008216	FDA UDI	Class II	Active
Custom Procedure Kit	4001602	FDA UDI	Class II	Active
Custom Procedure Kit	4000586	FDA UDI	Class I	Unknown
Essential Kit	4000923	FDA UDI	Class II	Active
FiberFlo	93022-085	FDA UDI	Class II	Unknown
Custom Procedure Kit	4001464	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	103816	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-605000-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000106	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106368-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200155-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4001587	FDA UDI	Class II	Active
Custom Procedure Kit	4000142	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo SmartCap Fujjifilm Adapter	100560	EUDAMEDFDA UDI	Class I	Active
Endo Carry-On Procedure Kit	CPK-103398-0002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101919	FDA UDI	Class II	Active
FiberFlo	93250-205	FDA UDI	Class II	Unknown
Medivators Hookup	Hookup	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.