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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 23 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4002624	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008042	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-351900-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104258-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006841	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104331-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009210	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4010152	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008049	FDA UDI	Class II	Active
Custom Procedure Kit	4005475	FDA UDI	Class II	Active
Endo Smartcap	100165	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007503	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102459-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010286	FDA UDI	Class II	Active
Custom Procedure Kit	4003182	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100959	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-736500-0005	FDA UDI	Class I	Unknown
FiberFlo	93022-086	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	100868	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001400	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106694-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103207-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009091	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007539	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-110504-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000187	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200155-0005	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004391	FDA UDI	Class II	Active
Custom Procedure Kit	4004860	FDA UDI	Class II	Active
Custom Procedure Kit	4000859	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000631	FDA UDI	Class II	Active
Scope Buddy Plus Tubing	SB-110-HU1010	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101241-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4006108	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	4001291	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-200155-0003	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4009003	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-111647-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106651-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200234-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000574	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007511	FDA UDI	Class II	Active
Custom Procedure Kit	4000528	FDA UDI	Class I	Unknown
Endo Smartcap	100165CO2EXT	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010671	FDA UDI	Class II	Active
Custom Procedure Kit	4000849	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002132	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-103773-0033	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102684-0003	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.