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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 25 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4002991	FDA UDI	Class II	Active
Renasol Bicarbonate Concentrate Powder	BC-1	FDA UDI	Class II	Unknown
Custom Procedure Kit	4002298	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103793-0003	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-571714-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009932	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-103768-0003	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-605000-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100964	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-136855-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-100080-0002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-645311-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-660000-0006	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008085	FDA UDI	Class II	Active
Custom Procedure Kit	4000123	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009836	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007968	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009599	FDA UDI	Class II	Active
Custom Procedure Kit	4002388	FDA UDI	Class I	Unknown
FiberFlo	93022-081	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-109795-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002636	FDA UDI	Class II	Active
Custom Procedure Kit	4000843	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000229	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009492	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008032	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-238500-0010	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4006075	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-103911-0003	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-351	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008123	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-104232-0010	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-110504-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101954	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106370-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-843955-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009047	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010287	FDA UDI	Class II	Active
FiberFlo	93250-028	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4007821	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106941-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008954	FDA UDI	Class II	Active
Custom Procedure Kit	4001040	FDA UDI	Class I	Unknown
Preclean Kit	4000906	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007728	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-105192-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4010500	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010589	FDA UDI	Class II	Active
Custom Procedure Kit	4003184	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.