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

Flowmeter, Tube, Thorpe, Back-Pressure Compensated (CAX) (10)

Premarket Exempt

No Yes

Clear

GENTEC® - 06970966663141 Catalog Number :

Device Description : FM197A Series, Flowmeter, Oxygen, 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® - 06970966663158 Catalog Number :

Device Description : FM197B Series, Flowmeter, Oxygen, 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® - 06970966663165 Catalog Number :

Device Description : FMD197A Series, Dual Flowmeter, Oxygen, 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® - 06970966663172 Catalog Number :

Device Description : FMD197B Series, Dual Flowmeter, Oxygen, 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® - 06970966663189 Catalog Number :

Device Description : FM897A Series, Flowmeter with humidifier, Oxygen, 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® - 06970966663196 Catalog Number :

Device Description : FM897B Series, Flowmeter with humidifier, Oxygen, 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® - 06970966663202 Catalog Number :

Device Description : FM187A Series, Flowmeter, 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® - 06970966663219 Catalog Number :

Device Description : FM187B Series, Flowmeter, 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® - 06970966663226 Catalog Number :

Device Description : FMD187A Series, Dual Flowmeter, 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® - 06970966663233 Catalog Number :

Device Description : FMD187B Series, Dual Flowmeter, 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

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