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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 49 of 104

Device	Model / Reference	Registries	Class	Status
FiberFlo	93250-115	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000249	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006273	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009801	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100797-0008-33	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-110120-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107641-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009887	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-108075-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008849	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-864000-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102877	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4001232	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010409	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010472	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103505-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004871	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-920000-0004	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107493-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102899	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4001902	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008287	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-663055-0005	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-110907-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003339	FDA UDI	Class II	Active
Custom Procedure Kit	4000345	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008530	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-393320-0001	FDA UDI	Class II	Active
Custom Procedure Kit	4000670	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100810	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-103822-0004	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-107324-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4001455	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-101241-0005	FDA UDI	Class I	Unknown
ENDOGATOR Kit	100652	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102856	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-129480-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010638	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104241-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100960	FDA UDI	Class I	Unknown
Endo Carry-On Custom Procedure Kit	4005873	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010326	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
FiberFlo	93022-066	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-105163-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-914045-0005	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.