Device
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 a...
Manufacturer
D R BURTON HEALTHCARE, LLC
D R BURTON HEALTHCARE, LLC
Model: 1
Catalog: 533
DI: 10851232007582
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4b752ceb-f073-4092-929c-bc66a53044b3
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:
20851232007084
Item #1 - Pkg Status:
Not in Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10851232007582
Item #1 - Pkg Discontinue Date:
2026-04-24
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10851232007582
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 31266
Name: Incentive spirometer
Definition:
A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device.
FDA Product Codes
BWF
Spirometer, Therapeutic (Incentive)
Premarket Submissions
Submission Number:
K160636
Supplement Number:
000