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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 28 of 104

Device	Model / Reference	Registries	Class	Status
Endo Carry-On Procedure Kit	102889	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4003353	FDA UDI	Class II	Active
Endo Smartcap	4005096	FDA UDI	Class II	Active
Custom Procedure Kit	4003584	FDA UDI	Class II	Active
Custom Procedure Kit	4001526	FDA UDI	Class II	Active
Custom Procedure Kit	4000636	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-238500-0009	FDA UDI	Class I	Unknown
ENDOGATOR Kit	100650B	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-759920-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-105304-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008149	FDA UDI	Class II	Active
Minncare HD	3029764	FDA UDI	Class II	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008338	FDA UDI	Class II	Active
Custom Procedure Kit	CPK-911525-0002	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103352-0001	FDA UDI	Class I	Unknown
Custom Procedure Kit	4000802	FDA UDI	Class II	Active
Custom Procedure Kit	4003952	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	102886	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100864	FDA UDI	Class II	Active
Custom Procedure Kit	4001301	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-129480-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-108324-0001	FDA UDI	Class II	Active
Trial Procedure Kit	CPKT-111139-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-822905-0001	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo-Carry-on Procedure Kit	4008564	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-916000-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	103915	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100994	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009034	FDA UDI	Class II	Active
Custom Procedure Kit	4000341	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-108396-0005	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	104888	FDA UDI	Class II	Active
Custom Procedure Kit	4002747	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPKT-102774-0002	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-441700-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104854-0003	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010392	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101861	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006146	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-111456-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-100100-0003	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-100797-0006	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	101981	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPK-104298-0001	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	100830	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006842	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4006133	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.