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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 6 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4000133	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-105638-0002	FDA UDI	Class I	Unknown
Intercept	100902	FDA UDI	Class I	Active
Custom Procedure Kit	4003410	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-465900-0001-33	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100918	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008420	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103855-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102901	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108327-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102827	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107330-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-782404-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-110353-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100727-0010	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002692	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008113	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101826	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000703	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104604-0001	FDA UDI	Class II	Active
Endogator	100110	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	102939	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100950	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109902-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4010509	FDA UDI	Class II	Active
Custom Procedure Kit	4000033	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007970	FDA UDI	Class II	Active
Custom Procedure Kit	4002501	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008730	FDA UDI	Class II	Active
Custom Procedure Kit	4002478	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108565-0004	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-103986-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-238500-0016	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108396-0004	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009205	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-200461-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-912220-0002-33	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-109418-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009846	FDA UDI	Class II	Active
Custom Procedure Kit	4005632	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-597000-0004	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-470015-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009370	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008052	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104344-0002	FDA UDI	Class II	Active
FiberFlo	93022-024	FDA UDI	Class II	Unknown
Centrisol Acid Concentrate	SB-344	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.