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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 18 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-on Procedure Kit	4009175	FDA UDI	Class II	Active
Custom Procedure Kit	4001606	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-102652-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-259000-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003183	FDA UDI	Class II	Active
Custom Procedure Kit	4000854	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105953-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-110120-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101970	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009411	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101855	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007228	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-105729-0002	FDA UDI	Class I	Unknown
Endogator	100125F	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-107774-0003	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010630	FDA UDI	Class II	Active
Essential Kit	4001142	FDA UDI	Class II	Active
Custom Procedure Kit	4000964	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-105657-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-597000-0006	FDA UDI	Class I	Unknown
Endo Carry-on Custom Procedure Kit	4005758	FDA UDI	Class II	Active
Rapicide PA Test Strips	ML020118	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007854	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009513	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-829600-0003	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102138-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-111075-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105123-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105623-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-605000-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-817020-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000137	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	101845	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000992	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001278	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-103436-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009808	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-107462-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004821	FDA UDI	Class II	Active
Custom Procedure Kit	4000973	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003548	FDA UDI	Class II	Active
Custom Procedure Kit	4001936	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008331	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101879	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-914350-0001	FDA UDI	Class I	Unknown
FiberFlo	93023-255	FDA UDI	Class II	Active
FiberFlo	93022-133	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-108984-0005	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.