drburtonhpi.comD R Burton OxyPAP
D R Burton Healthcare, LLC
D R BURTON HEALTHCARE, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012970776 | 3012970776 | D R BURTON HEALTHCARE, LLC | 1 | N | 2026-01-01 | 3936 S FIELDS ST Farmville NC US 27828 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00851232007011 | vPEP OPEP DEVICE - This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device. | 2522287038 | inquiries@drburtonhpi.com |
| 00851232007028 | vPEP-HC - This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device. | 2522287038 | inquiries@drburtonhpi.com |
| 00851232007080 | vPEP-HC OPEP DEVICE WITH T-PIECE ADAPTER - Single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device. | 2522287038 | inquiries@drburtonhpi.com |
| 00851232007097 | T-PIECE ADAPTER - 22mm O.D. x 28mm I.D. x 22mm I.D. T-PIECE ADAPTER W/ MOUTHPIECE FOR POCKETPEP | 2522287038 | inquiries@drburtonhpi.com |
| 00851232007103 | T-PIECE ADAPTER - 22mm O.D. x 28mm I.D. x 22mm I.D. MOUTHPIECE T-PIECE ADAPTER FOR VPEP | 2522287038 | inquiries@drburtonhpi.com |
| 00851232007110 | J-Wand Advantage - Single-use, rigid intubating stylet. | 2522287038 | inquiries@drburtonhpi.com |
| 00851232007127 | vPEP - Single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device. | 2522287038 | inquiries@drburtonhpi.com |
| 00851232007134 | OxyPAP PAP DEVICE WITH UNIVERSAL CUFF ADAPTER - The OxyPAP PAP DEVICE WITH UNIVERSAL CUFF ADAPTER is a positive airway pressure (PAP) therapy device which incorporates a positive end expiratory pressure (PEEP) valve which also has the ability to deliver supplemental oxygen when used with compressed oxygen. | 2522287038 | inquiries@drburtonhpi.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 199125 | 1467041909 | K192000 | D R Burton OxyPAP | BWF | 2020-02-19 |
| 199125 | 1628735255 | K160636 | iPEP System and vPEP | BWF | 2016-08-03 |
| 199125 | 1085076954 | ||||
| 199125 | 1376380173 | ||||
| 199125 | 1556831412 | ||||
| 199125 | 1603950075 | ||||
| 199125 | 1694628559 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| BWF | 2 | 2020-02-19 |
PMN#
GUDID#
vPEP OPEP DEVICE - This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2017-01-27
vPEP-HC - This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2018-10-24
vPEP-HC OPEP DEVICE WITH T-PIECE ADAPTER - Single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2026-04-28
T-PIECE ADAPTER - 22mm O.D. x 28mm I.D. x 22mm I.D. T-PIECE ADAPTER W/ MOUTHPIECE FOR POCKETPEP
2019-08-23
T-PIECE ADAPTER - 22mm O.D. x 28mm I.D. x 22mm I.D. MOUTHPIECE T-PIECE ADAPTER FOR VPEP
2019-08-23
J-Wand Advantage - Single-use, rigid intubating stylet.
2019-07-03
vPEP - Single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2026-04-28
OxyPAP PAP DEVICE WITH UNIVERSAL CUFF ADAPTER - The OxyPAP PAP DEVICE WITH UNIVERSAL CUFF ADAPTER is a positive airway pressure (PAP) therapy device which incorporates a positive end expiratory pressure (PEEP) valve which also has the ability to deliver supplemental oxygen when used with compressed oxygen.
2026-04-28
OxyPAP PAP DEVICE w/o MANOMETER - The OxyPAP PAP DEVICE w/o MANOMETER 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.
2026-04-28
OxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMETER - 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.
2026-04-28
RTech REUSABLE INTUBATION STYLET - Reusable, rigid intubating stylet.
2026-04-28
RTech STERILE DISPOSABLE INTUBATION STYLET - Single-use, rigid intubating stylet.
2026-04-28
RTech NON-STERILE DISPOSABLE INTUBATION STYLET - Single-use, rigid intubating stylet.
2026-04-28
J-WAND ADVANTAGE INTUBATION STYLET, NON-STERILE - Single-use, rigid intubating stylet.
2026-04-28
OXYJET VENTURI DEVICE WITH TUBING - 1
2026-04-28
iPEP - This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2018-01-02
PocketPEP Advantage - This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2021-07-01
PocketPEP - This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2018-01-02
PocketPEP OPEP DEVICE w/ T-PIECE ADAPTER & MOUTHPIECE - Single-patient, multi-use device is intended for use as an Oscillating Positive Expiratory Pressure (OPEP) device. The vPEP is intended to be used with patients that can generate an exhaled flow of 10 liters per minute for 3 – 4 seconds.
2026-04-28
NUT AND NIPPLE ADAPTOR - "Oxygen Tubing Adaptor that is a barbed oxygen concentrator adaptor made with a hex screw used to connect oxygen tubing to a medical gas termial unit. Also known as a ""Christmas Tree Adaptor"". "
2026-04-28
T-PIECE ADAPTER - 22mm O.D. x 28mm I.D. x 22mm I.D. x 4.5mmO.D. Jet T-PIECE ADAPTOR w/o Manometer MOUTHPIECE ADAPTER
2019-08-23
PocketPEP with OxyJET - A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxygen when used with compressed oxygen.
2020-04-10
OxyJet - 1
2019-08-23
OxyPAP - 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.
2020-02-24
PocketPEP Advantage with OxyJET - A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compressed oxygen.
2020-04-10
OxyBREATH NON-MEASURING EXERCISER - The OxyBREATH is a respiratory muscle trainer (RMT). It trains both inspiratory and expiratory muscles independently.
2026-04-28
OxyTrainer ADVANTAGE - The OxyTrainer Advantage is a respiratory muscle trainer (RMT). It trains both inspiratory and expiratory muscles independently.
2026-04-28
Disposable Pressure Manometer - The disposable pressure manometer provides visual indication of airway pressure.
2020-02-28
J-Wand - Single Use Semi-rigid Intubating Stylet.
2019-05-01
vPEP - This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2017-01-27
vPEP-HC - This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2018-10-24
iPEP - This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2018-01-02
PocketPEP - This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2018-01-02
PocketPEP Advantage - This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
2021-07-01
PocketPEP with OxyJET - A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxygen when used with compressed oxygen.
2020-04-10
PocketPEP Advantage with OxyJET - A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compressed oxygen.
2020-04-10
J-Wand Advantage - Single-use, rigid intubating stylet.
2019-07-03
T-PIECE ADAPTER - 22mm O.D. x 28mm I.D. x 22mm I.D. MOUTHPIECE ADAPTER
2019-08-23
T-PIECE ADAPTER - 22mm O.D. x 28mm I.D. x 22mm I.D. MOUTHPIECE ADAPTER
2019-08-23
T-PIECE ADAPTER - 22mm O.D. x 28mm I.D. x 22mm I.D. x 4.5mmO.D. MOUTHPIECE ADAPTER
2019-08-23