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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 55 of 104

Device	Model / Reference	Registries	Class	Status
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
ENDOGATOR Kit	100620	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010428	FDA UDI	Class II	Active
FiberFlo	93250-191	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008121	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009220	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103773-0015	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008021	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-328500-0003	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105383-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010035	FDA UDI	Class II	Active
Custom Procedure Kit	4000414	FDA UDI	Class II	Active
Custom Procedure Kit	4010507	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101955	FDA UDI	Class II	Active
Custom Procedure Kit	4002384	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000978	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101215-0009-33	FDA UDI	Class I	Unknown
Rapicide OPA/28 Test Strips	ML02-0137	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008847	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009902	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006143	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009913	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	CPK-200404-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101937	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103773-0019	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108545-0001	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-108654-0006	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-305025-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000979	FDA UDI	Class II	Active
Custom Procedure Kit	4000643	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104232-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004705	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101835	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008389	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007551	FDA UDI	Class II	Active
Custom Procedure Kit	4005148	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104282-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108327-0006	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-107946-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004881	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103974-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007480	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-660000-0004	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008873	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200169-0005	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-827100-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008231	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.