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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 66 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-on Procedure Kit	4005931	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-100096-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108255-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108327-0004	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008112	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104661-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-259000-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-110774-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009786	FDA UDI	Class II	Active
Custom Procedure Kit	4003765	FDA UDI	Class II	Active
Custom Procedure Kit	4004016	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-102774-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009858	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101941	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-829600-0001	FDA UDI	Class I	Unknown
Outset Acid Concentrate	A-325	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-914700-0009	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101910	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008048	FDA UDI	Class II	Active
EndoGator Hybrid	4003179	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104344-0004	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009878	FDA UDI	Class II	Active
Custom Procedure Kit	4002613	FDA UDI	Class II	Active
Custom Procedure Kit	4000090	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106672-0004	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008704	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102684-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109782-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108014-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104401-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010573	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-103407-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101958	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102933-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101881	FDA UDI	Class II	Active
Custom Procedure Kit	4000963	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009851	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102688-0005	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-583400-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108494-0001	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-144	FDA UDI	Class II	Unknown
FiberFlo	93250-010	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-101276-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009592	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101215-0008-33	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-101512-0002	FDA UDI	Class I	Unknown
Endogator	100136P	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4001584	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-110007-0002	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.