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) (5) Flowmeter, Tube, Thorpe, Back-Pressure Compensated (CAX) (4) Tubing, Pressure And Accessories (BYX) (1)

Premarket Exempt

No Yes

Clear

GENTEC® - 06970966663240 Catalog Number :

Device Description : FM887A Series, Flowmeter with humidifier, Air, Aluminum, 1L,3L,6L,15L,50L,70L.

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAX

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663257 Catalog Number :

Device Description : FM887B Series, Flowmeter with humidifier, Air, Brass, 1L,3L,6L,15L,50L,70L.

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAX

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663264 Catalog Number :

Device Description : CFM Series, Oxygen, Click Style,4L,8L,15,25L.

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663271 Catalog Number :

Device Description : FM293 Series, Flowmeter, Oxygen, Back pressure compensated,200cc,1L,3L,16L,75L.

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAX

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663288 Catalog Number :

Device Description : FM293 Series, Flowmeter, Air, Back pressure compensated,200cc,1L,3L,16L,75L.

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAX

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663295 Catalog Number :

Device Description : 284 Series, Medical Gas Regulator, Click Style,Oxygen,Brass & Aluminum

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663301 Catalog Number :

Device Description : 285 Series, Medical Gas Regulator, Click Style,Oxygen,Brass & Aluminum

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663318 Catalog Number :

Device Description : 286 Series, Medical Gas Regulator, Click Style,Oxygen,N2O,Brass

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663325 Catalog Number :

Device Description : 287 Series, Medical Gas Regulator, Click Style,Air,Brass & Aluminum

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

GENTEC® - 06970966663332 Catalog Number :

Device Description : 288 Series, Medical Gas Regulator, Click Style,Air,Brass & Aluminum

Device Class : 1

Duns Number: 545287658

Premarket Exempt : Yes

Product Code : CAN

Prescription Use : No

Device Count : 1

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