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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 91 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	CPK-814900-0001	FDA UDI	Class II	Active
Custom Procedure Kit	4001607	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-100190-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010536	FDA UDI	Class II	Active
ENDOGATOR hybrid irrigation tubing	100610	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103571-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-298000-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200432-0003	FDA UDI	Class I	Unknown
Essential Kit	4000925	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107893-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107474-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-104702-0004	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000241	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104759-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102929	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008866	FDA UDI	Class II	Active
Custom Procedure Kit	4000830	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102840	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100951	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006147	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104353-0001	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-101276-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001497	FDA UDI	Class II	Active
CER-1 Optima	CER-1 Optima	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102815	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101962	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100939	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-460800-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106602-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100100-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-205390-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-110007-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-597000-0005	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009374	FDA UDI	Class II	Active
Intercept Detergent	ML02-0106	FDA UDI	Class I	Active
Endo Carry-on Procedure Kit	4010064	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-823900-0008	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000366	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-914700-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004342	FDA UDI	Class II	Active
Micro Pull Thru Cassette Refill (180x12)	4002606	FDA UDI	Class I	Active
Endo-Carry-on Procedure Kit	4008813	FDA UDI	Class II	Active
Custom Procedure Kit	4000725	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008856	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008046	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102912	FDA UDI	Class II	Active
Essential Kit	4000939	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008422	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.