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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 75 of 104

Device	Model / Reference	Registries	Class	Status
Endo-Carry-on Procedure Kit	4007977	FDA UDI	Class II	Active
Renasol Acid Concentrate	SB-1020	FDA UDI	Class II	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4003318	FDA UDI	Class II	Active
Custom Procedure Kit	4003746	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-200104-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200529-0004	FDA UDI	Class II	Active
Renalin 100	78397-844	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009872	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009731	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110359-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006224	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009120	FDA UDI	Class II	Active
Custom Procedure Kit	4002920	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-814900-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
FiberFlo	93022-061	FDA UDI	Class II	Unknown
Centrisol Bicarbonate Concentrate Powder	MB-330-15	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-200108-0004	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4004527	FDA UDI	Class II	Active
Custom Procedure Kit	4003325	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-609105-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009848	FDA UDI	Class II	Active
Essential Kit	4001958	FDA UDI	Class II	Active
Custom Procedure Kit	4000071	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008770	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102612-0005	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108117-0001	FDA UDI	Class II	Active
Custom Procedure Kit	4000962	FDA UDI	Class II	Active
Gasjet CO2 Delivery System	EGA-501T	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	101850	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100536-0001	FDA UDI	Class I	Unknown
Endo Smartcap	100162	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-109159-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-102656-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008247	FDA UDI	Class II	Active
Essential Kit	4000928	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200093-0002	FDA UDI	Class I	Unknown
Scope Buddy Adapter	SB-110-HU1005	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-551050-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003117	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-110564-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-785600-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100801	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-107331-0002	FDA UDI	Class I	Unknown
ENDOGATOR Kit	100654	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010376	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102419-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009363	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.