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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 57 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	CPK-102655-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-782404-0009	FDA UDI	Class I	Unknown
FiberFlo	93022-057	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000847	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-200427-0004	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009124	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007804	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009981	FDA UDI	Class II	Active
Renasol Acid Concentrate	SB-1076	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	101975	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009844	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009009	FDA UDI	Class II	Active
Preclean Kit	4000903	FDA UDI	Class II	Active
Centrisol Acid Concentrate	SB-344	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-817020-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010375	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009760	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106408-0006	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104197-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108671-0003-33	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009117	FDA UDI	Class II	Active
FiberFlo	93022-103	FDA UDI	Class II	Unknown
Hemocor HPH	HPH 700	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	100880	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000837	FDA UDI	Class II	Active
Custom Procedure Kit	4001585	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110353-0002	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010401	FDA UDI	Class II	Active
DentaPure 365-Day Municipal Cartridge	DPI365M	FDA UDI	Class I	Active
Custom Procedure Kit	4000263	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004345	FDA UDI	Class II	Active
Custom Procedure Kit	4000640	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007710	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101851	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002171	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106672-0003	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000143	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009412	FDA UDI	Class II	Active
Custom Procedure Kit	4001475	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-200432-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000388	FDA UDI	Class I	Unknown
Custom Procedure Kit	4005770	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101938	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107331-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107560-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103207-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003795	FDA UDI	Class II	Active
Custom Procedure Kit	4000425	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.