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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 10 of 104

Device	Model / Reference	Registries	Class	Status
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103900-0001	FDA UDI	Class I	Unknown
Endo Smartcap	100555	FDA UDI	Class II	Active
Custom Procedure Kit	4000296	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-108984-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006518	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-759000-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009991	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009044	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101935	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010480	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100915	FDA UDI	Class II	Active
Renalin Residual Test Strips	78198-000	FDA UDI	Class II	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009139	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107320-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4001401	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102858	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102810	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009232	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009172	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-109970-0001	FDA UDI	Class I	Unknown
EndoGator Hybrid	4003166	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009031	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101913	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007702	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-110255-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-110534-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-108984-0007	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-606051-0001	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000635	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001846	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000032	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-205695-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-351900-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106480-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100953	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106106-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200698-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104232-0006	FDA UDI	Class II	Active
Custom Procedure Kit	4000193	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-107938-0001	FDA UDI	Class I	Unknown
FiberFlo	93250-143	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPKT-106778-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-104344-0008	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-103773-0034	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.