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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 11 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	101857	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100699-0004	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010361	FDA UDI	Class II	Active
Actril Cold Sterilant	78337-000	FDA UDI	Class II	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105469-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200155-0010	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008166	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-110207-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107330-0006	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103773-0016	FDA UDI	Class I	Unknown
Essential Kit	4000933	FDA UDI	Class II	Active
Custom Procedure Kit	4003326	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100957	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009867	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-200763-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-606600-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000865	FDA UDI	Class II	Active
Custom Procedure Kit	4005673	FDA UDI	Class II	Active
ENDOGATOR Kit	100655B	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-107462-0001	FDA UDI	Class I	Unknown
ENDOGATOR Kit	100628	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103349-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-631099-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007996	FDA UDI	Class II	Active
Custom Procedure Kit	4002836	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009116	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008879	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007889	FDA UDI	Class II	Active
Custom Procedure Kit	4003950	FDA UDI	Class II	Active
Preclean Kit	4000893	FDA UDI	Class II	Active
Hemocor HPH	HPH 400TS	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-105192-0003	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009153	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008795	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007333	FDA UDI	Class II	Active
Custom Procedure Kit	4001903	FDA UDI	Class I	Unknown
FiberFlo	93022-068	FDA UDI	Class II	Unknown
Endo Carry-On Custom Procedure Kit	4005870	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008237	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104344-0009	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008526	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-104358-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010529	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-110585-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100222-0002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-914045-0004	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-251200-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105252-0001	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.