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 th...
Manufacturer
D R BURTON HEALTHCARE, LLC
D R BURTON HEALTHCARE, LLC
Model: 1
Catalog: 510
DI: 00851232007011
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2017-01-27
Current Version: 2026-05-21
Description
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
9
Record Key:
cadf38d1-a876-481c-8fcf-ccec9ca4d6f9
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 - Device ID:
00851232007011
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
case
Item #2 - Device ID:
10851232007049
Item #2 - Pkg Status:
Not in Commercial Distribution
Item #2 - Pkg Quantity:
10
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00851232007011
Item #2 - Pkg Discontinue Date:
2026-04-24
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
case
Item #3 - Device ID:
10851232007032
Item #3 - Pkg Status:
Not in Commercial Distribution
Item #3 - Pkg Quantity:
2
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00851232007011
Item #3 - Pkg Discontinue Date:
2026-04-24
Item #3 - Device ID Issuing Agency:
GS1
Item #4 - Pkg Type:
case
Item #4 - Device ID:
10851232007001
Item #4 - Pkg Status:
Not in Commercial Distribution
Item #4 - Pkg Quantity:
10
Item #4 - Device ID Type:
Package
Item #4 - Contains DINumber:
00851232007011
Item #4 - Pkg Discontinue Date:
2026-04-24
Item #4 - Device ID Issuing Agency:
GS1
Item #5 - Pkg Type:
box
Item #5 - Device ID:
10851232007063
Item #5 - Pkg Status:
Not in Commercial Distribution
Item #5 - Pkg Quantity:
12
Item #5 - Device ID Type:
Package
Item #5 - Contains DINumber:
10851232007001
Item #5 - Pkg Discontinue Date:
2026-04-24
Item #5 - Device ID Issuing Agency:
GS1
Item #6 - Pkg Type:
box
Item #6 - Device ID:
10851232007056
Item #6 - Pkg Status:
Not in Commercial Distribution
Item #6 - Pkg Quantity:
6
Item #6 - Device ID Type:
Package
Item #6 - Contains DINumber:
10851232007001
Item #6 - Pkg Discontinue Date:
2026-04-24
Item #6 - Device ID Issuing Agency:
GS1
Item #7 - Pkg Type:
CASE
Item #7 - Device ID:
20851232007015
Item #7 - Pkg Status:
In Commercial Distribution
Item #7 - Pkg Quantity:
10
Item #7 - Device ID Type:
Package
Item #7 - Contains DINumber:
00851232007011
Item #7 - 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