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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 72 of 104

Device	Model / Reference	Registries	Class	Status
Endo-Carry-on Procedure Kit	4007272	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-104091-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101872	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000030	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009143	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200700-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100860	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008282	FDA UDI	Class II	Active
Custom Procedure Kit	4003976	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110314-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-606000-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Cer-1	CER-1	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007940	FDA UDI	Class II	Active
Custom Procedure Kit	4000991	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100822	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4010622	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105351-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPKT-109325-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009070	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009982	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104604-0003	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007519	FDA UDI	Class II	Active
Custom Procedure Kit	4001971	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-663055-0004	FDA UDI	Class II	Active
Custom Procedure Kit	4000269	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-110023-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-298000-0006	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104027-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100974	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010546	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-205350-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009417	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101834	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000255	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108309-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008874	FDA UDI	Class II	Active
Custom Procedure Kit	4001031	FDA UDI	Class I	Unknown
FiberFlo	93023-147	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-200106-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008035	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-824800-0001	FDA UDI	Class II	Active
Custom Procedure Kit	4003337	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007824	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009265	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007798	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106682-0002	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.