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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 19 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-on Procedure Kit	4009227	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010408	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009767	FDA UDI	Class II	Active
Custom Procedure Kit	4002510	FDA UDI	Class I	Unknown
Renasol Acid Concentrate	SB-1077	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-111494-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009277	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4009002	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100877	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003931	FDA UDI	Class II	Active
FiberFlo	93022-087	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009041	FDA UDI	Class II	Active
Custom Procedure Kit	4001470	FDA UDI	Class II	Active
Custom Procedure Kit	4000230	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-103880-0003	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009350	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103571-0002	FDA UDI	Class I	Unknown
DentaPure 365-Day Municipal Cartridge	DP365M10	FDA UDI	Class I	Active
Custom Procedure Kit	CPK-109325-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108999-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-110585-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008881	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-881020-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-294120-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008308	FDA UDI	Class II	Active
Mini Pull Thru 60pk W/ Cassette, Mount	4002601	FDA UDI	Class I	Active
Trial Procedure Kit	CPKT-575000-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007969	FDA UDI	Class II	Active
FiberFlo	93250-008	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-101084-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Micro Pull Thru Cassette Refill (360x12)	4002607	FDA UDI	Class I	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010621	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-782404-0006	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002273	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010407	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007782	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-107331-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104702-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106602-0003	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-104614-0002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-844500-0006	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009931	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108349-0008	FDA UDI	Class II	Active
Irrigation Tubing	100130P	FDA UDI	Class II	Unknown
Endo Smartcap	100145CO2	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.