Device
A handheld oscillating positive expiratory pressure device with the ability to deliver supplemental oxygen when used with compressed oxygen.
Manufacturer
D R BURTON HEALTHCARE, LLC
Model: 1 Catalog: 538 DI: 00851232007721 Status: Update MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2020-04-10 Current Version: 2026-05-21 Distribution End: 2026-04-24
Description
A handheld oscillating positive expiratory pressure device with 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: 5
Record Key: f73a2b13-48a3-489f-b7aa-574eb8d61cd1
Distribution Status: Not in Commercial Distribution
DUNS Number: 080384219
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: Yes
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: 20851232007725
Item #1 - Pkg Status: Not in Commercial Distribution
Item #1 - Pkg Quantity: 10
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00851232007721
Item #1 - Pkg Discontinue Date: 2026-04-24
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00851232007721
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