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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 98 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4003431	FDA UDI	Class II	Active
Custom Procedure Kit	4001523	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106846-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-822925-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008132	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-104232-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102807	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100816	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009192	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007851	FDA UDI	Class II	Active
Custom Procedure Kit	4002619	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-100352-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPKT-103794-0001-33	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009824	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009772	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009292	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009426	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010033	FDA UDI	Class II	Active
FiberFlo	93250-179	FDA UDI	Class II	Unknown
Endo Carry-on Procedure Kit	4010433	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-911500-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-109462-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-104080-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107440-0001	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-480875-0004	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101927	FDA UDI	Class I	Unknown
Custom Procedure Kit	4003411	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-205390-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008755	FDA UDI	Class II	Active
Custom Procedure Kit	4000874	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009814	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008734	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009467	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-393320-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4005964	FDA UDI	Class II	Active
Custom Procedure Kit	4001570	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-102612-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-103773-0038	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-103735-0004	FDA UDI	Class II	Active
Centrisol Acid Concentrate	SB-351	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-358000-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4010503	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110585-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-103407-0003	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-143	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-200332-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009107	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007249	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-109283-0001	FDA UDI	Class I	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.