AccessGUDID - DEVICE: Disposable Pressure ManometerSingle Patient Use (05707480032372)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Pressure ManometerSingle Patient Use
Version or Model: 322004000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 322004000
Company Name: Ambu A/S

Primary DI Number: 05707480032372
Issuing Agency: GS1
Commercial Distribution End Date: May 27, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: Manometer - 20PCS/BOX, 12BOXES/T30BOX US

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46634	Airway pressure monitor, non-powered	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAP	MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -18 and 50 Degrees Celsius
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 6.4 Gram
Length: 55 Millimeter
Outer Diameter: 22 Millimeter

Device Record Status

Public Device Record Key: 1d2f6b3d-710c-4930-8937-6a60b6b8258e
Public Version Date: June 29, 2023
Public Version Number: 4
DI Record Publish Date: September 21, 2016