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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 69 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4000863	FDA UDI	Class I	Unknown
Renasol Acid Concentrate	SB-1057	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPKT-111426-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107493-0004	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003473	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
FiberFlo	93023-236	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009502	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4008992	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009812	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007283	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-110195-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107324-0004	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008164	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009521	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104684-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000131	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-583050-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009215	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009351	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101918	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108683-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-916660-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-105644-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102659-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000180	FDA UDI	Class I	Unknown
FiberFlo	93022-113	FDA UDI	Class II	Unknown
Scope Buddy	EFA-US-G	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008872	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008280	FDA UDI	Class II	Active
Custom Procedure Kit	4000122	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108396-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106405-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009918	FDA UDI	Class II	Active
Preclean Kit	4000894	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-102632-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-101048-0007-33	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-572410-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010569	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009242	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009199	FDA UDI	Class II	Active
Custom Procedure Kit	4001442	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-103773-0036	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003472	FDA UDI	Class II	Active
Custom Procedure Kit	4001943	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-759920-0002	FDA UDI	Class I	Unknown
EndoGator Hybrid	4003181	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-660000-0001	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.