Device
The disposable pressure manometer provides visual indication of airway pressure.
Manufacturer
D R BURTON HEALTHCARE, LLC
D R BURTON HEALTHCARE, LLC
Model: 1
Catalog: 566
DI: 00851232007752
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2020-02-28
Current Version: 2026-05-21
Description
The disposable pressure manometer provides visual indication of airway pressure.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
4
Record Key:
9997e7cc-d542-4005-a6c9-e1748e5a982e
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:
50851232007757
Item #1 - Pkg Status:
Not in Commercial Distribution
Item #1 - Pkg Quantity:
50
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00851232007752
Item #1 - Pkg Discontinue Date:
2026-04-27
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00851232007752
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
CASE
Item #3 - Device ID:
20851232007756
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
10
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00851232007752
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 46634
Name: Airway pressure monitor, non-powered
Definition:
A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.
FDA Product Codes
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Premarket Submissions
Submission Number:
K192000
Supplement Number:
000