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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 9 of 104

Device	Model / Reference	Registries	Class	Status
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000104	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007554	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	104915	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-103938-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101925	FDA UDI	Class I	Unknown
ENDOGATOR Kit	100653	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010000	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008565	FDA UDI	Class II	Active
Custom Procedure Kit	4002296	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103144-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101967	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4007120	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107774-0004	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
ENDOGATOR Kit	100620B	FDA UDI	Class II	Active
Custom Procedure Kit	4001286	FDA UDI	Class II	Active
Custom Procedure Kit	4000310	FDA UDI	Class II	Active
Custom Procedure Kit	4000181	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-105144-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200843-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-457000-0006	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009477	FDA UDI	Class II	Active
Custom Procedure Kit	4003222	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009119	FDA UDI	Class II	Active
Endogator Kit	4005470	FDA UDI	Class II	Active
Custom Procedure Kit	4000572	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101215-0005	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100797-0009	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010394	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200625-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004486	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108565-0003	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010171	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103911-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-104232-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104533-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-109380-0005	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008328	FDA UDI	Class II	Active
Custom Procedure Kit	4003474	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106205-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102805-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-717700-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000674	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010651	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-108042-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002741	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.