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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 94 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4000832	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103144-0003	FDA UDI	Class II	Active
Custom Procedure Kit	4004861	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008309	FDA UDI	Class II	Active
Micro Pull Thru 60pk W/ Cassette, Mount	4002605	FDA UDI	Class I	Active
Custom Procedure Kit	4005047	FDA UDI	Class II	Active
Custom Procedure Kit	4000961	FDA UDI	Class II	Active
Custom Procedure Kit	4000356	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100817	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200192-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-101241-0007	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102873	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-782404-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103195-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000974	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010640	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101960	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008596	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-111477-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009296	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008020	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007948	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006151	FDA UDI	Class II	Active
Hemocor HPH	HPH 700TS	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-200585-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108349-0005	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-107474-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007997	FDA UDI	Class II	Active
Custom Procedure Kit	4003872	FDA UDI	Class II	Active
Custom Procedure Kit	4001987	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102688-0010	FDA UDI	Class II	Active
Custom Procedure Kit	4000405	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108999-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007356	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105352-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109902-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-238500-0015	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009885	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108672-0003	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200115-0001	FDA UDI	Class I	Unknown
Renasol Acid Concentrate	SB-1070	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-200767-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010029	FDA UDI	Class II	Active
Custom Procedure Kit	4001444	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008527	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101215-0003	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110521-0001	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.