Question 1

What types of medical devices does Maquet Critica Care AB manufacture?

Accepted Answer

Maquet Critica Care AB specializes in mechanical ventilators. Their primary product, the Servo-air 4.0 Ventilator System, is designed to provide respiratory support in clinical environments. This device is intended for patients requiring assisted or controlled ventilation, such as those in intensive care or recovery settings.

Question 2

Where is Maquet Critica Care AB based, and how does this affect its regulatory oversight?

Accepted Answer

Maquet Critica Care AB is based in the United States. Since the company operates within the U.S., its devices are subject to regulatory oversight by the FDA. The Servo-air 4.0 Ventilator System, for example, is classified under the FDA’s 510(k) pathway, meaning it must demonstrate substantial equivalence to a legally marketed predicate device to enter the market.

Question 3

Which regulatory registries or databases list Maquet Critica Care AB’s devices?

Accepted Answer

The Servo-air 4.0 Ventilator System is listed under the FDA’s 510(k) pathway, indicating it has undergone the required premarket notification process. This means the device is documented in the FDA’s 510(k) registry, which tracks medical devices that have been cleared through this pathway. This registry serves as a public record of devices authorised for sale in the U.S.

Question 4

How are Maquet Critica Care AB’s devices classified under medical device regulations?

Accepted Answer

The Servo-air 4.0 Ventilator System is classified as a Class II medical device. This classification is determined by the FDA based on the device’s intended use and potential risk. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance. The classification influences the regulatory pathway the device must follow before being authorised for market.

Device	Model / Reference	Registries	Class	Status
PiCCO Catheter	PV2014L16	EUDAMED	Class IIa	Active
Compressor Mini 220-240V 50/60Hz	6481787	EUDAMED	Class IIa	Active
PiCCO Monitoring Kits	PV8615	EUDAMED	Class IIb	Active
SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1	K180098	FDA 510(k)	Class II	Active
Servo-I Ventilator System, Model 64 87 800 E407e	K040221	FDA 510(k)	Class II	Active
Guide Wire For Edi Catheter, 8fr, 125cm, 5 Each, Guide Wire For Edi Catheter, 8fr, 125cm, 5 Each, Guide Wire For Edi Catheter,	K101199	FDA 510(k)	Class II	Active
SERVO-U Ventilator System, SERVO-n Ventilator System	K151814	FDA 510(k)	Class II	Active
Servo-air Lite Ventilator System	K230173	FDA 510(k)	Class II	Active
Servo-I Ventilator System, Models 64, 87 And 800	K063404	FDA 510(k)	Class II	Active
Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585	K073179	FDA 510(k)	Class II	Active
Modification To Servo-I Ventilator System, Model 64 87 800 E407e	K041223	FDA 510(k)	Class II	Active
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System	K191027	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Servo-I Ventilator System, Model 64 87 800 E407e; Nava Option	K062793	FDA 510(k)	Class II	Active
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40	K160665	FDA 510(k)	Class II	Active
Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1	K201874	FDA 510(k)	Class II	Active
Servo-air 4.0 Ventilator System	K192604	FDA 510(k)	Class II	Active
Servo-I Ventilator System	K123149	FDA 510(k)	Class II	Active
Flow-I Anesthesia System C20, C30 & C40	K133958	FDA 510(k)	Class II	Active
Flow-i C30	6677300	EUDAMEDFDA UDI	Class IIb	Active
Breathing bag Anesthesia, Disposable 0.5L	6692215	EUDAMEDFDA UDI	Class IIa	Active
ITS Housing	PV4046	EUDAMED	Class IIa	Active
Breathing system, 22 mm (for HME) 1, 5m	6691957	EUDAMEDFDA UDI	Class IIa	Active
Servo-u MR Ventilator System	6888800	EUDAMEDFDA UDI	Class IIb	Active
Servo Guard	6595487	EUDAMEDFDA UDI	Class IIa	Active
Servo-u Ventilator System	6694800	EUDAMEDFDA UDI	Class IIb	Active
Guide wire for Edi Catheter 6 Fr	6671270	EUDAMEDFDA UDI	Class I	Active
Edi Catheter ENFit 6Fr/49cm	6883898	EUDAMED	Class IIa	Active
Flow-i C40	6888540	EUDAMEDFDA UDI	Class IIb	Active
Servo-c Ventilator System	6882000	EUDAMEDFDA UDI	Class IIb	Active
Flow-i C30	6888530	EUDAMEDFDA UDI	Class IIb	Active
Servo-c Ventilator System	6890000	EUDAMED	Class IIb	Active
Gas Sampling line 3.5 m	6887043	EUDAMEDFDA UDI	Class IIa	Active
Guide wire for Edi Catheter 8 Fr 100 cm	6671272	EUDAMEDFDA UDI	Class I	Active
Servo-n Ventilator System	6688600	EUDAMEDFDA UDI	Class IIb	Active
Flow-i C40	6677400	EUDAMEDFDA UDI	Class IIb	Active
Flow-i C20	6677200	EUDAMEDFDA UDI	Class IIb	Active
Non Invasive Ventilation face mask, size S	6691980	EUDAMEDFDA UDI	Class IIa	Active
Gas Sampling line 2.5m	6887042	EUDAMEDFDA UDI	Class IIa	Active
Flow-c	6887700	EUDAMEDFDA UDI	Class IIb	Active
Guide wire for Edi Catheter 8 Fr 125 cm	6671292	EUDAMEDFDA UDI	Class I	Active
Servo Duo Guard	6671775	EUDAMEDFDA UDI	Class IIa	Active
PiCCO Monitoring Kits	PV8215	EUDAMED	Class IIb	Active
ProAQT Sensor	PV8810	EUDAMED	Class IIb	Active
Edi Catheter ENFit 8Fr/100cm	6883901	EUDAMEDFDA UDI	Class IIa	Active
Edi Catheter ENFit 6Fr/48cm	6893166	EUDAMED	Class IIa	Active
Edi Catheter ENFit 6Fr/50cm	6883899	EUDAMEDFDA UDI	Class IIa	Active
Flow-i C20	6888520	EUDAMEDFDA UDI	Class IIb	Active
PiCCO Catheter	PV2014L08	EUDAMED	Class IIa	Active

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