D R BURTON HEALTHCARE, LLC

Address:3936 S FIELDS ST,Farmville,NC,27828,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

Spirometer, Therapeutic (Incentive) (BWF) (3) Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (CAP) (2) Mask, Oxygen, Low Concentration, Venturi (BYF) (1)

Premarket Exempt

No Yes

Clear

PocketPEP with OxyJET - 10851232007681 Catalog Number : 537

Device Description : A handheld oscillating positive expiratory pressure device for secretion clearan A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxygen when used with compressed oxygen.

Device Class : 2

Duns Number: 080384219

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

OxyJet - 10851232007704 Catalog Number :

Device Class :

Duns Number: 080384219

Premarket Exempt : Yes

Product Code : BYF

Prescription Use : Yes

Device Count : 1

OxyPAP - 10851232007711 Catalog Number :

Device Description : The OxyPAP is a positive airway pressure (PAP) therapy device which incorporates The OxyPAP is a positive airway pressure (PAP) therapy device which incorporates a positive end expiratory pressure (PEEP) valve and which also has the ability to deliver supplemental oxygen when used with compressed oxygen.

Device Class :

Duns Number: 080384219

Premarket Exempt : No

Product Code : BWF, CAP

Prescription Use : Yes

Device Count : 1

PocketPEP Advantage with OxyJET - 10851232007728 Catalog Number : 538

Device Description : A handheld oscillating positive expiratory pressure device with the ability to d A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compressed oxygen.

Device Class : 2

Duns Number: 080384219

Premarket Exempt : No

Product Code : BWF

Prescription Use : Yes

Device Count : 1

Disposable Pressure Manometer - 10851232007759 Catalog Number : 566

Device Description : The disposable pressure manometer provides visual indication of airway pressure.

Device Class : 2

Duns Number: 080384219

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

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