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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 88 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	CPK-104398-0001	FDA UDI	Class I	Unknown
Centrisol Acid Concentrate	SB-352	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008008	FDA UDI	Class II	Active
Custom Procedure Kit	4001617	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-785600-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-107698-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009197	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-103822-0003	FDA UDI	Class I	Unknown
FiberFlo	93250-157	FDA UDI	Class II	Unknown
Custom Procedure Kit	4000357	FDA UDI	Class I	Unknown
Renasol Bicarbonate Concentrate Powder	BC-1-15	FDA UDI	Class II	Active
ENDO STRATUS CO2 Insufflator	EGA-501	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-104284-0001	FDA UDI	Class I	Unknown
Hemocor HPH	HPH 400	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-105224-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000119	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107698-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-104641-0010	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-102656-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004424	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110512-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100727-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	102868	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Trial Procedure Kit	CPKT-110120-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-200106-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009892	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010045	FDA UDI	Class II	Active
Custom Procedure Kit	4000844	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010301	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-683100-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-305025-0002	FDA UDI	Class I	Unknown
FiberFlo	93022-019	FDA UDI	Class II	Unknown
Custom Procedure Kit	CPK-782404-0010	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009841	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007273	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009919	FDA UDI	Class II	Active
Custom Procedure Kit	4003264	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009843	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008039	FDA UDI	Class II	Active
Custom Procedure Kit	4002621	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007222	FDA UDI	Class II	Active
Custom Procedure Kit	4004863	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-867500-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108577-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Centrisol Acid Concentrate	SB-151	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-571714-0001	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009826	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.