Gyrus Acmi, Inc.

Address:800 West Park Drive,Westborough,MA,01581,US

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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

Valve, Pulmonary (NJK) (6) One-Way Air-Leak Valve (OAZ) (2)

Premarket Exempt

No Yes

Clear

Spiration Valve System - 00896506002200 Catalog Number :

Device Description : Valve in Cartridge, 9mm

Device Class :

Duns Number: 117521967

Premarket Exempt : No

Product Code : OAZ

Prescription Use : No

Device Count : 1

Spiration Valve System - 00896506002217 Catalog Number :

Device Description : Airway Sizing Kit

Device Class :

Duns Number: 117521967

Premarket Exempt : No

Product Code : OAZ

Prescription Use : No

Device Count : 1

Spiration Valve System - 00896506002279 Catalog Number :

Device Description : Valve in Cartridge, 7mm

Device Class : 3

Duns Number: 117521967

Premarket Exempt : No

Product Code : NJK

Prescription Use : Yes

Device Count : 1

Spiration Valve System - 00896506002286 Catalog Number :

Device Description : Valve in Cartridge , 5mm

Device Class : 3

Duns Number: 117521967

Premarket Exempt : No

Product Code : NJK

Prescription Use : Yes

Device Count : 1

Spiration Valve System - 00896506002293 Catalog Number :

Device Description : Valve in Cartridge, 6mm

Device Class : 3

Duns Number: 117521967

Premarket Exempt : No

Product Code : NJK

Prescription Use : Yes

Device Count : 1

Spiration Valve System - 00896506002309 Catalog Number :

Device Description : Valve in Cartridge, 9mm

Device Class : 3

Duns Number: 117521967

Premarket Exempt : No

Product Code : NJK

Prescription Use : Yes

Device Count : 1

Spiration Valve System - 00896506002316 Catalog Number :

Device Description : Deployment Catheter and Loader, 2.6

Device Class : 3

Duns Number: 117521967

Premarket Exempt : No

Product Code : NJK

Prescription Use : Yes

Device Count : 1

Spiration Valve System - 00896506002323 Catalog Number :

Device Description : Airway Sizing Kit

Device Class : 3

Duns Number: 117521967

Premarket Exempt : No

Product Code : NJK

Prescription Use : Yes

Device Count : 1

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