GVS Technology (Suzhou) Co., Ltd.

Address:No. 602 Changjiang Road,Suzhou Jiangsu,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

Filter, Bacterial, Breathing-Circuit (CAH) (7) Condenser, Heat And Moisture (Artificial Nose) (BYD) (3)

Premarket Exempt

No Yes

Clear

ECO Range - Midi Series - 15019315083259 Catalog Number :

Device Class :

Duns Number: 420798347

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 1

ECO Range - Maxi Series - 15019315083297 Catalog Number :

Device Class : 2

Duns Number: 420798347

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 1

ECO Range - Midi Series - 15019315083303 Catalog Number :

Device Class : 2

Duns Number: 420798347

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 1

ECO Range Phase 1 - 15019315083341 Catalog Number :

Device Class :

Duns Number: 420798347

Premarket Exempt : Yes

Product Code : CAH

Prescription Use : No

Device Count : 1

ECO Maxi Filter - 15060120952629 Catalog Number :

Device Class :

Duns Number: 420798347

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 50

ECO Maxi HME - 15060120952636 Catalog Number :

Device Class :

Duns Number: 420798347

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 50

ECO Micro HMEF - 15060120952643 Catalog Number :

Device Class :

Duns Number: 420798347

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 50

ECO HME - 15060120952650 Catalog Number :

Device Class :

Duns Number: 420798347

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 50

ECO Mini HMEF - 15060120952667 Catalog Number :

Device Class :

Duns Number: 420798347

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 50

ECO Range - 15060120952674 Catalog Number :

Device Class :

Duns Number: 420798347

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 50

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