GENTEC(SHANGHAI)CORPORATION

Address:NO. 499 WENJI ROAD,SHANGHAI,CN

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Regulator, Pressure, Gas Cylinder (CAN) (9) Regulator, Vacuum (KDP) (1)

Premarket Exempt

No Yes

Clear

GENTEC® - 06970966663349 Catalog Number :

Device Description : 195MG Series, Medical Gas Regulator, Oxygen,Air,N2O, Brass

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663356 Catalog Number :

Device Description : 195MA Series, Medical Gas Regulator, Oxygen, Brass

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663363 Catalog Number :

Device Description : 195MZ Series, Medical Gas Regulator, Oxygen,Air,N2O,CO2,N2, Brass

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663370 Catalog Number :

Device Description : 191M Series, Medical Gas Regulator, Oxygen, Brass

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663387 Catalog Number :

Device Description : 195M Series, Medical Gas Regulator, Oxygen,Air,N2O,CO2, Brass

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663394 Catalog Number :

Device Description : 197M Series, Medical Gas Regulator, Oxygen,Air,N2O, Brass

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663400 Catalog Number :

Device Description : 230M Series, Medical Gas Regulator, Oxygen, Brass

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663417 Catalog Number :

Device Description : 152M Series, Medical Gas Regulator, Oxygen,Air, Brass

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663448 Catalog Number :

Device Description : 880VS series medical suction kit is a continuous suction kit powered from pressu 880VS series medical suction kit is a continuous suction kit powered from pressure gas. This is a long term, non-invasive, active medical device. It can be used to medical suction for tracheal suction, pharyngeal aspiration, gastro-intestinal drainage, and surgical suction.

Device Class : 2

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : KDP

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663455 Catalog Number :

Device Description : 191M Series, Medical Gas Regulator with flowmeter, Oxygen,Air,N2O, Brass

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

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