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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 54 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4000970	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-110916-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100797-0007	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009092	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008880	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007943	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-111336-0002	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-103407-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001009	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-101026-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008252	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006542	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4004018	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105729-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001518	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008977	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010590	FDA UDI	Class II	Active
Custom Procedure Kit	4000413	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000252	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006144	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-616590-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105383-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-660000-0003	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008281	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010595	FDA UDI	Class II	Active
Custom Procedure Kit	4000428	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008886	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	4001145	FDA UDI	Class II	Active
Endogator Hybrid Irrigation Tubing	4000838	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107841-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008727	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-500175-0001	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-105256-0002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108422-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009820	FDA UDI	Class II	Active
Custom Procedure Kit	4001094	FDA UDI	Class I	Unknown
Adult Bite Block	100411	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106375-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-606800-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-104684-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-108984-0006	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000285	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010538	FDA UDI	Class II	Active
FiberFlo	93022-026	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000727	FDA UDI	Class I	Unknown
FiberFlo	93250-009	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-200016-0002	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.