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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 7 of 104

Device	Model / Reference	Registries	Class	Status
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-130745-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000511	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009732	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100872	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104027-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002491	FDA UDI	Class II	Active
Custom Procedure Kit	4000282	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-111	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008053	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104344-0010	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-102138-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106694-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002896	FDA UDI	Class I	Unknown
Endo SmartCap	100164CO2EXTU	FDA UDI	Class II	Unknown
Custom Procedure Kit	4001905	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006543	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108059-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007656	FDA UDI	Class II	Active
Custom Procedure Kit	4005109	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-109519-0005	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001071	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105470-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-894200-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008093	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007840	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100876	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-576600-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100797-0010	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009123	FDA UDI	Class II	Active
Custom Procedure Kit	4001013	FDA UDI	Class II	Active
Defendo	Defendo Fujifilm 700 Series	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-823900-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-101316-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104356-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200585-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-103773-0041	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-205390-0005	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008432	FDA UDI	Class II	Active
Custom Procedure Kit	4001429	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008330	FDA UDI	Class II	Active
Custom Procedure Kit	4003476	FDA UDI	Class II	Active
Custom Procedure Kit	4002387	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104163-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010574	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010358	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104641-0007	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008101	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-110399-0003	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.