Question 1

What types of medical devices does Barkey GmbH & Co. KG manufacture?

Accepted Answer

Barkey GmbH & Co. KG specializes in conduction-based blood and fluid warmers. These devices are designed to maintain or increase the temperature of intravenous fluids and blood products during medical procedures, ensuring optimal patient outcomes. Examples include the Barkey S-line series and the plasmatherm line, as well as the Barkey warming center III DTM system for controlled warming applications.

Question 2

Where is Barkey GmbH & Co. KG based?

Accepted Answer

Barkey GmbH & Co. KG is headquartered in Germany. The company’s location in Germany aligns with its focus on manufacturing and distributing medical devices that comply with European and international regulatory standards.

Question 3

In which regulatory registries are Barkey GmbH & Co. KG’s devices listed?

Accepted Answer

Barkey GmbH & Co. KG’s devices are registered in multiple key regulatory databases, including the EU’s EUDAMED system for medical device tracking, the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) database. These registries ensure transparency and compliance with global medical device regulations.

Question 4

How are Barkey GmbH & Co. KG’s devices classified under medical device regulations?

Accepted Answer

Barkey GmbH & Co. KG’s devices are classified under the EU Medical Device Regulation as either Class II or Class IIa. This classification reflects their moderate risk level, requiring compliance with specific safety and performance standards to ensure they meet regulatory requirements for use in clinical settings.

Barkey GmbH & Co. KG

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Device	Model / Reference	Registries	Class	Status
Barkey S-line	39 °C	FDA UDI	Class II	Active
plasmatherm	00000474	EUDAMED	Class IIa	Active
plasmatherm	00009935	EUDAMED	Class IIa	Active
plasmatherm	00011290	EUDAMED	Class IIa	Active
Barkey S-line	00011159	EUDAMED	Class IIa	Active
plasmatherm	00000478	EUDAMED	Class IIa	Active
plasmatherm	00010343	EUDAMED	Class IIa	Active
plasmatherm	00000476	EUDAMED	Class IIa	Active
plasmatherm	00003291	EUDAMED	Class IIa	Active
plasmatherm	00003296	EUDAMEDFDA UDI	Class IIa	Active
Barkey S-line	00011144	EUDAMED	Class IIa	Active
Barkey warming center III DTM	00011193	EUDAMED	Class IIa	Active
plasmatherm	00010334	EUDAMED	Class IIa	Active
Barkey S-line	00011155	EUDAMED	Class IIa	Active
plasmatherm	00010446	EUDAMED	Class IIa	Active
Barkey S-line	00011164	EUDAMED	Class IIa	Active
plasmatherm	00000508	EUDAMED	Class IIa	Active
Prismacomfort, Model Autocontrol 3xpt With Autoline Xpt 4r	K071909	FDA 510(k)	Class II	Active
plasmatherm	00010341	EUDAMED	Class IIa	Active
plasmatherm	0000472	EUDAMED	Class IIa	Active
plasmatherm	00000465	EUDAMED	Class IIa	Active
Barkey S-line	00011154	EUDAMED	Class IIa	Active
plasmatherm	00000489	EUDAMED	Class IIa	Active
Barkey S-line	00011143	EUDAMED	Class IIa	Active
plasmatherm	00003357	EUDAMED	Class IIa	Active
warming center II	00011186	EUDAMED	Class IIa	Active
warming center II	00011182	EUDAMED	Class IIa	Active
plasmatherm	00010346	EUDAMED	Class IIa	Active
plasmatherm	00003285	EUDAMED	Class IIa	Active
warming center II	00011179	EUDAMED	Class IIa	Active
plasmatherm	00003495	EUDAMED	Class IIa	Active
plasmatherm	00000520	EUDAMED	Class IIa	Active
plasmatherm	00000487	EUDAMED	Class IIa	Active
Barkey S-line	00011171	EUDAMED	Class IIa	Active
plasmatherm	00000506	EUDAMED	Class IIa	Active
plasmatherm	00009947	EUDAMED	Class IIa	Active
Barkey warming center III DTM	00011293	EUDAMED	Class IIa	Active
Barkey S-line	00011145	EUDAMED	Class IIa	Active
plasmatherm	00010331	EUDAMED	Class IIa	Active
plasmatherm	00010339	EUDAMED	Class IIa	Active
plasmatherm	00000466	EUDAMED	Class IIa	Active
Barkey S-line	00011152	EUDAMED	Class IIa	Active
plasmatherm	00010840	EUDAMED	Class IIa	Active
plasmatherm	00010337	EUDAMED	Class IIa	Active
plasmatherm	00000488	EUDAMED	Class IIa	Active
warming center II	00011188	EUDAMED	Class IIa	Active
plasmatherm	00000460	EUDAMEDFDA UDI	Class IIa	Active
warming center II	00011175	EUDAMED	Class IIa	Active
warming center II	00011176	EUDAMED	Class IIa	Active
plasmatherm	00000503	EUDAMED	Class IIa	Active