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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 51 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-on Procedure Kit	4009104	FDA UDI	Class II	Active
Custom Procedure Kit	4000597	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-914045-0007	FDA UDI	Class II	Active
FiberFlo	93250-177	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-238500-0014	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102849	FDA UDI	Class I	Unknown
Renalin 100	78397-846	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101974	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100820	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-339325-0001	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-119	FDA UDI	Class II	Unknown
Custom Procedure Kit	4003478	FDA UDI	Class II	Active
Endo Smartcap	100551	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009298	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4000346	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPKT-103067-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-106655-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-108673-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000873	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002953	FDA UDI	Class II	Active
Custom Procedure Kit	4000420	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107324-0008	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003223	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009261	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009768	FDA UDI	Class II	Active
Scope Buddy Plus Tubing	SB-110-HU1015	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009260	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104695-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000682	FDA UDI	Class II	Active
Custom Procedure Kit	4004349	FDA UDI	Class II	Active
Custom Procedure Kit	4000729	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103880-0002-33	FDA UDI	Class I	Unknown
Custom Procedure Kit	4010502	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008124	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009042	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104854-0006	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-305025-0003	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102933-0001	FDA UDI	Class II	Active
FiberFlo	93022-054	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4009171	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104641-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-105350-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107268-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-499900-0003	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008374	FDA UDI	Class II	Active
Custom Procedure Kit	4004334	FDA UDI	Class II	Active
Custom Procedure Kit	4002194	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.