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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 47 of 104

Device	Model / Reference	Registries	Class	Status
ENDOGATOR Kit	100614	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-110843-0001	FDA UDI	Class I	Unknown
ENDOGATOR Kit	100602	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	200800	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107334-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003977	FDA UDI	Class II	Active
ENDOGATOR hybrid irrigation tubing	100606B	FDA UDI	Class II	Active
Essential Kit	4002041	FDA UDI	Class II	Active
Preclean Kit	4000909	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-103407-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-663055-0006	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010059	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008846	FDA UDI	Class II	Active
Custom Procedure Kit	4000949	FDA UDI	Class I	Unknown
DEFENDO Disposable Biopsy Valve	100318	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	100814	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-100194-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002426	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010561	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105072-0002	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-143	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000589	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008887	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007897	FDA UDI	Class II	Active
Cleanascope Essential Kit	4001959	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4005411	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-891800-0003	FDA UDI	Class I	Unknown
Essential Kit	4000945	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104702-0003	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	103885	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-200155-0009	FDA UDI	Class I	Unknown
Endo Smartcap	4005095	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-268950-0001	FDA UDI	Class I	Unknown
FiberFlo	93023-149	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-103773-0028	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007787	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009517	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104859-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-200104-0003	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009827	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107330-0008	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-200763-0004	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4000323	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100797-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-101215-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-814900-0002	FDA UDI	Class I	Unknown
Renasol Bicarbonate Concentrate Powder	BC-1-25	FDA UDI	Class II	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.