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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 83 of 104

Device	Model / Reference	Registries	Class	Status
Endo-Carry-on Procedure Kit	4008373	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-111321-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-827100-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107161-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002170	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105644-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4000363	FDA UDI	Class II	Active
Intercept Plus	4002404	FDA UDI	Class I	Active
Trial Procedure Kit	CPKT-106841-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102730-0003	FDA UDI	Class I	Unknown
Hemocor HPH	HPH 1400TS	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-676405-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002380	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-105729-0002	FDA UDI	Class II	Active
Hemocor HPH	HPH 1400	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-104600-0003	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008732	FDA UDI	Class II	Active
Custom Procedure Kit	4000652	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200625-0002	FDA UDI	Class II	Active
Custom Procedure Kit	4001423	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	4001134	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101971	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4002584	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4002385	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-111224-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000747	FDA UDI	Class II	Active
Custom Procedure Kit	4004873	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009880	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009522	FDA UDI	Class II	Active
Custom Procedure Kit	4003908	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4001857	FDA UDI	Class II	Active
Custom Procedure Kit	4000840	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009069	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108297-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
FiberFlo	93022-114	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000983	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-238500-0011	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010174	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-103911-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-101048-0008-33	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007495	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-530095-0003	FDA UDI	Class II	Active
Preclean Kit	4000907	FDA UDI	Class II	Active
Double Balloon Pull Thru Single	4002608	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.