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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 59 of 104

Device	Model / Reference	Registries	Class	Status
Endo-Carry-on Procedure Kit	4008288	FDA UDI	Class II	Active
Custom Procedure Kit	4003412	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-880500-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107493-0002	FDA UDI	Class I	Unknown
ENDOGATOR Kit	100625	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104648-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006242	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009803	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008794	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-107324-0009	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104664-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000272	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104272-0001	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-200698-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008385	FDA UDI	Class II	Active
Centrisol Acid Concentrate	SB-342	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-100536-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-111254-0001	FDA UDI	Class I	Unknown
Preclean Kit	4001125	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-321050-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103490-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-822925-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200802-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109782-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010571	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104419-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100895	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102419-0002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100849	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009121	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009886	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-105163-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-645311-0005-33	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-823900-0005	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-108396-0007	FDA UDI	Class I	Unknown
FiberFlo	93250-093	FDA UDI	Class II	Unknown
FiberFlo	93022-017	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009297	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103773-0022	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007946	FDA UDI	Class II	Active
Custom Procedure Kit	4004124	FDA UDI	Class II	Active
Essential Kit	4000941	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200211-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-100422-0002	FDA UDI	Class II	Active
Custom Procedure Kit	4002616	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-490975-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-735000-0002	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.