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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 17 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-on Procedure Kit	4009360	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-107425-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103974-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo SmartCap	100164U	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4007978	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-200787-0002	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200487-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101944	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008888	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008726	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200286-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000726	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104083-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010025	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008306	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007553	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006153	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-912220-0003	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-200155-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106480-0003	FDA UDI	Class I	Unknown
FiberFlo	93250-121	FDA UDI	Class II	Unknown
FiberFlo	93022-172	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-829520-0001	FDA UDI	Class I	Unknown
Outset Acid Concentrate	A-225	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPKT-105131-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009501	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-470015-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200397-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009897	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-106590-0001	FDA UDI	Class I	Unknown
Rapicide PA High-Level Disinfectant	ML02-0117	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	104891	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106408-0004	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009903	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010001	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007520	FDA UDI	Class II	Active
Essential Kit	4000924	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106408-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	103819	FDA UDI	Class II	Active
ENDOGATOR Kit	100621	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-106205-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-102138-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-110515-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4010515	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008082	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006291	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.