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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 53 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4000186	FDA UDI	Class II	Active
Custom Procedure Kit	4002299	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103225-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103773-0007	FDA UDI	Class I	Unknown
ENDO STRATUS Irrigation Pump	EGA-500	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106682-0003	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-200842-0001	FDA UDI	Class I	Unknown
Conmed Endogator Pump	CETEGP-100	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-109649-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009066	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-200568-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105802-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100854	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-595500-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-107323-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104787-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105856-0002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104854-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106682-0001	FDA UDI	Class I	Unknown
Scope Buddy Plus	SBP-1000	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007490	FDA UDI	Class II	Active
Custom Procedure Kit	4003187	FDA UDI	Class II	Active
Endogator	200230B	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009282	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103352-0006	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010562	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008115	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-597000-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-205390-0009	FDA UDI	Class I	Unknown
FiberFlo	93250-030	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4007949	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102814	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100886	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-259900-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101888	FDA UDI	Class II	Active
ENDOGATOR Kit	100655	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-759000-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000210	FDA UDI	Class II	Active
Custom Procedure Kit	4001029	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000784	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-106205-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009440	FDA UDI	Class II	Active
Custom Procedure Kit	4000870	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010458	FDA UDI	Class II	Active
Custom Procedure Kit	4002615	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-103773-0035	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.