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 the...
Manufacturer
D R BURTON HEALTHCARE, LLC
D R BURTON HEALTHCARE, LLC
Model: 1
Catalog: 535
DI: 00851232007554
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2021-07-01
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:
5
Record Key:
e7794705-431a-4935-b9f2-f33c3e276732
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:
00851232007554
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
CASE
Item #2 - Device ID:
20851232007558
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
10
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00851232007554
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