OxyPAP
GUDID 10851232007711
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.
D R BURTON HEALTHCARE, LLC
Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered| Primary Device ID | 10851232007711 |
| NIH Device Record Key | 540ca6ce-3688-4c71-846c-c95a98eb75d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OxyPAP |
| Version Model Number | 1 |
| Company DUNS | 080384219 |
| Company Name | D R BURTON HEALTHCARE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10851232007711 [Primary] |
| GS1 | 30851232007715 [Package] Package: CASE [10 Units] In Commercial Distribution |
| GS1 | 40851232007712 [Package] Package: CASE [10 Units] In Commercial Distribution |
| GS1 | 50851232007719 [Package] Package: CASE [10 Units] In Commercial Distribution |
| GS1 | 60851232007716 [Package] Package: CASE [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192000
FDA Product Code
| BWF | Spirometer, Therapeutic (Incentive) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-03 |
| Device Publish Date | 2020-02-24 |
Devices Manufactured by D R BURTON HEALTHCARE, LLC
| 10851232007018 - vPEP | 2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp |
| 10851232007025 - vPEP-HC | 2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp |
| 10851232007520 - iPEP | 2023-11-17 This is a single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive exp |
| 10851232007568 - PocketPEP | 2023-11-17 This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expi |
| 10851232007551 - PocketPEP Advantage | 2021-07-09 This is a single patient multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expi |
| 30851232007685 - PocketPEP with OxyJET | 2020-04-20 A handheld oscillating positive expiratory pressure device for secretion clearance with the ability to deliver supplemental oxyg |
| 30851232007722 - PocketPEP Advantage with OxyJET | 2020-04-20 A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compre |
| 30851232007111 - J-Wand Advantage | 2020-03-27 Single-use, rigid intubating stylet. |
Trademark Results [OxyPAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXYPAP 87951288 not registered Live/Pending |
D R Burton Healthcare, LLC 2018-06-06 |
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