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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 89 of 104

Device	Model / Reference	Registries	Class	Status
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4007510	FDA UDI	Class II	Active
Custom Procedure Kit	4002297	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-109115-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008882	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008370	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100845	FDA UDI	Class I	Unknown
Pull Thru 60pk W/ Cassette And Mount	4002595	FDA UDI	Class I	Active
Endo Carry-on Procedure Kit	4010542	FDA UDI	Class II	Active
Endo-Carry-on Procedure Kit	4008223	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4005965	FDA UDI	Class II	Active
Custom Procedure Kit	4000584	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-606600-0002	FDA UDI	Class I	Unknown
Endo Carry-On	102800	FDA UDI	Class II	Active
Custom Procedure Kit	4010508	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Stubby	Stubby Brush	FDA UDI	Class I	Active
Double Balloon Pull Thru W/ Stubby Combo	4002609	FDA UDI	Class I	Active
Endo Carry-On Procedure Kit	CPK-110968-0003	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Unknown
Endo Carry-On Procedure Kit	CPK-103773-0011	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-104104-0002	FDA UDI	Class I	Unknown
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-539060-0001	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Custom Procedure Kit	4000965	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	CPKT-103773-0007	FDA UDI	Class I	Unknown
Trial Procedure Kit	CPKT-104600-0002	FDA UDI	Class I	Unknown
Custom Procedure Kit	CPK-111494-0002	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4009805	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010646	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-110515-0003	FDA UDI	Class I	Unknown
Endo Carry-On Procedure Kit	200802	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	103888	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4010567	FDA UDI	Class II	Active
Custom Procedure Kit	4010516	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-107334-0001	FDA UDI	Class I	Unknown
Endo Carry-on Procedure Kit	4010359	FDA UDI	Class II	Active
Medivators Hookup	Hookup	FDA UDI	Class II	Active
Endo Carry-on Procedure Kit	4009276	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	101983	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	100863	FDA UDI	Class I	Unknown
Custom Procedure Kit	4002340	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-533950-0002	FDA UDI	Class I	Unknown
Endo-Carry-on Procedure Kit	4008430	FDA UDI	Class II	Active
Custom Procedure Kit	4003221	FDA UDI	Class II	Active
Micro Pull Thru Single	4002604	FDA UDI	Class I	Active
Custom Procedure Kit	4004862	FDA UDI	Class II	Active
Endo Carry-On Procedure Kit	CPK-103352-0004	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.