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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 101 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	CPK-100194-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-106947-0001	FDA UDI	Class I	Unknown
Rapicide OPA/28 High-Level Disinfectant	ML02-0127	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101889	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107516-0005	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108226-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-111291-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003185	FDA UDI	Class II	Active
Custom Procedure Kit	4001465	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100933	FDA UDI	Class II	Active
Custom Procedure Kit	4004707	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008045	FDA UDI	Class II	Active
Custom Procedure Kit	4003909	FDA UDI	Class II	Active
Actril Cold Sterilant	4001944	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000841	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106373-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009754	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-205695-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009063	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-109462-0001	FDA UDI	Class II	Active
ENDOGATOR Kit	100611	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010010	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-108673-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100836	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	101914	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-103407-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-111321-0004	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-195000-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010678	FDA UDI	Class II	Active
FiberFlo	93250-150	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-110562-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000134	FDA UDI	Class I	Unknown
ENDOGATOR Kit	100658	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-106258-0001	FDA UDI	Class I	Unknown
Centrisol Bicarbonate Concentrate Powder	MB-330-25	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008860	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008529	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101812	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105644-0004	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200204-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001891	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009264	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007838	FDA UDI	Class II	Active
Custom Procedure Kit	4002635	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-914700-0006	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.