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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 4 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	CPK-100400-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-238500-0017	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106258-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108654-0004	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007270	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009859	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008595	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006535	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007947	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100694-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106815-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009454	FDA UDI	Class II	Active
Custom Procedure Kit	4003705	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101843	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101803	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110492-0001	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-129	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009850	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103773-0012	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4005909	FDA UDI	Class II	Active
Custom Procedure Kit	4000575	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-814900-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104743-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-432055-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009036	FDA UDI	Class II	Active
Hemocor HPH	HPH 1000	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-102044-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200155-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100857	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104069-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100373-0001	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-105470-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007886	FDA UDI	Class II	Active
Centrisol Liquid Bicarbonate Concentrate	MB-330-L	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009866	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009097	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007559	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007917	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007324	FDA UDI	Class II	Active
Custom Procedure Kit	4010520	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010579	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007418	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008122	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007363	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104887-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006284	FDA UDI	Class II	Active
Single Ended Channel Brush	100401	FDA UDI	Class I	Active

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.