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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 65 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4001474	FDA UDI	Class II	Active
Custom Procedure Kit	4000162	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-101241-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-894200-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108064-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008235	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009512	FDA UDI	Class II	Active
Endo Carry-on Custom Procedure Kit	4005776	FDA UDI	Class II	Active
Custom Procedure Kit	4000136	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000283	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107538-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-298000-0004	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103773-0017	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102688-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104854-0007	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101957	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104533-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103608-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-606600-0005	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-104344-0007	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000041	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009198	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008104	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009300	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-107425-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107326-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107437-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009293	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006530	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107760-0001	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-109380-0001	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-353	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101921	FDA UDI	Class II	Active
Custom Procedure Kit	4000118	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008812	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007357	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009523	FDA UDI	Class II	Active
Endogator	4005644	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008017	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009829	FDA UDI	Class II	Active
Custom Procedure Kit	4001984	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007944	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101862	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004706	FDA UDI	Class II	Active
Endo Carry-on Custom Procedure Kit	4005759	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102669-0001	FDA UDI	Class I	Unknown
FiberFlo	93022-064	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-108396-0004	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.