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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 21 of 104

Device	Model / Reference	Registries	Class	Status
Endo-Carry-on Procedure Kit	4007218	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009992	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-491013-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-238500-0007	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-102556-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102919	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200192-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102894	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-104550-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109004-0001	FDA UDI	Class I	Unknown
Hemocor HPH	HPH Mini	FDA UDI	Class II	Unknown
DispoCap Air	100160P	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-364305-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010023	FDA UDI	Class II	Active
Custom Procedure Kit	4000149	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102612-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107516-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002841	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106408-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100884	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endogator	200230	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101943	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103793-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102876	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102684-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101936	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-106317-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009590	FDA UDI	Class II	Active
Custom Procedure Kit	4001471	FDA UDI	Class II	Active
Renalin	78336-000	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-735000-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001437	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106325-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Minncare HD Residual Test Strips	3029795	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007894	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008196	FDA UDI	Class II	Active
Master Sample Kit	101900	FDA UDI	Class I	Unknown
Minncare HD	3029765	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4006073	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	104819	FDA UDI	Class II	Active
ENDOGATOR Kit	100616	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4007873	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100855	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100992	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009295	FDA UDI	Class II	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.