Spirometrics

Spirometrics

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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

Meter, Peak Flow, Spirometry (BZH) (4) Calibrator, Volume, Gas (BXW) (2) Mouthpiece, Breathing (BYP) (2) Device, Vein Location, Liquid Crystal (KZA) (1) Filter, Bacterial, Breathing-Circuit (CAH) (1)

Premarket Exempt

No Yes

Clear

Veinsite - 00855784004009 Catalog Number :

Device Description : Near infrared vein locator device with a liquid crystal display.

Device Class : 1

Duns Number: 830864406

Premarket Exempt : No

Product Code : KZA

Prescription Use : Yes

Device Count : 1

SpiroFlow - 00855784004016 Catalog Number : E5010-2

Device Description : Adult Peak Flow Meter

Device Class :

Duns Number: 830864406

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

SpiroFlow - 00855784004047 Catalog Number : E5020-2

Device Description : Child Peak Flow Meter

Device Class :

Duns Number: 830864406

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Spirometrics - 00855784004207 Catalog Number : N4010-2

Device Description : 3 Liter Calibration Syringe, Spirometrics label

Device Class : 1

Duns Number: 830864406

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : No

Device Count : 1

Spirometrics - 00855784004214 Catalog Number : N4010-2-VAC

Device Description : 3 Liter Calibration Syringe, OEM

Device Class : 1

Duns Number: 830864406

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : No

Device Count : 1

SpiroFlow - 00855784004245 Catalog Number : E5010-2-NOV

Device Description : Adult Peak Flow Meter

Device Class : 2

Duns Number: 830864406

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

SpiroFlow - 00855784004252 Catalog Number : E5020-2-NOV

Device Description : Child Peak Flow Meter

Device Class : 2

Duns Number: 830864406

Premarket Exempt : No

Product Code : BZH

Prescription Use : No

Device Count : 1

Spiro-Filter - 00855784004269 Catalog Number :

Device Description : TFP Breathing Filter

Device Class : 2

Duns Number: 830864406

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 1

Spirometrics - 00855784004276 Catalog Number :

Device Description : Pediatric Mouthpiece, each

Device Class : 1

Duns Number: 830864406

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 1

Spirometrics - 00855784004283 Catalog Number :

Device Description : Adult Mouthpiece, each

Device Class :

Duns Number: 830864406

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : No

Device Count : 1

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