Device
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 h...
Manufacturer
D R BURTON HEALTHCARE, LLC
D R BURTON HEALTHCARE, LLC
Model: 1
Catalog: 562-TS, 562-6
DI: 00851232007134
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-21
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
3
Record Key:
9fdea954-0669-4fd7-954d-8b43125f21b7
Distribution Status:
In Commercial Distribution
DUNS Number:
080384219
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
20851232007138
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00851232007134
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00851232007134
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
OVERPACK
Item #3 - Device ID:
30851232007135
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
6
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
20851232007138
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
BWF
Spirometer, Therapeutic (Incentive)
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Premarket Submissions
Submission Number:
K192000
Supplement Number:
000