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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 5 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	CPK-104148-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-200108-0002-33	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105123-0003	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009737	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007705	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009115	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008868	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108349-0006	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105104-0001	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008736	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007125	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-106559-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-103773-0013	FDA UDI	Class I	Active
Custom Procedure Kit	4000856	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009816	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006254	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110120-0005	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-104010-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4010505	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009423	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006154	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-103822-0001	FDA UDI	Class I	Unknown
ENDOGATOR Kit	100615	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-104258-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107516-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100839	FDA UDI	Class II	Active
Custom Procedure Kit	4000412	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000548	FDA UDI	Class I	Unknown
FiberFlo	93023-140	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-103261-0001	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103773-0002	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-111254-0002	FDA UDI	Class I	Unknown
Renaflo II Hemofilter	HF 1200	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008245	FDA UDI	Class II	Active
Custom Procedure Kit	4004482	FDA UDI	Class II	Active
Custom Procedure Kit	4000547	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-782404-0008	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104398-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010643	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-653000-0001-33	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100926-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-109970-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-111456-0003	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-109159-0002	FDA UDI	Class I	Active
Endo Carry-On Procedure Kit	CPK-844500-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-200104-0006	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-137002-0001	FDA UDI	Class I	Unknown
FiberFlo	93022-084	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-107379-0002	FDA UDI	Class II	Active
DEFENDO Disposable Suction and Biopsy Valve Kit	100320	FDA UDI	Class II	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.