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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 92 of 104

Device	Model / Reference	Registries	Class	Status
Custom Procedure Kit	4002951	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-110058-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-110564-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-137550-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4004433	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009895	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007242	FDA UDI	Class II	Active
ENDOGATOR Kit	100622B	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-110399-0004	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-104258-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-200104-0005	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-106842-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105227-0002	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010602	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100888	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-369030-0001	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4007976	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100893	FDA UDI	Class II	Active
Custom Procedure Kit	4003413	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007722	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103015-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-104191-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-200083-0001	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-104398-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000073	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	103887	FDA UDI	Class I	Unknown
Custom Procedure Kit	4001427	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009447	FDA UDI	Class II	Active
Custom Procedure Kit	4001078	FDA UDI	Class II	Active
Custom Procedure Kit	4000281	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-106402-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104661-0003	FDA UDI	Class II	Active
Custom Procedure Kit	4003340	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-100321-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-111000-0001	FDA UDI	Class II	Active
Endo Carry-on Custom Procedure Kit	4005882	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010639	FDA UDI	Class II	Active
Mini Pull	Pull Brush	FDA UDI	Class I	Active
Endo Carry-On Procedure Kit	CPK-101215-0006	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108327-0005	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-108191-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000130	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009424	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-200404-0005	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-100080-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-102688-0008	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-441700-0005	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.