DEVICE: Disposable Pressure ManometerSingle Patient Use (05707480032372)

Download: XML | JSON

Device Identifier (DI) Information

Disposable Pressure ManometerSingle Patient Use
322004000
322004000
Ambu A/S
05707480032372
GS1
1
Manometer - 20PCS/BOX, 12BOXES/T30BOX US
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -18 and 50 Degrees Celsius
Storage Environment Temperature: between -40 and 60 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Weight: 6.4 Gram
Length: 55 Millimeter
Outer Diameter: 22 Millimeter
CLOSE

Device Status

In Commercial Distribution
September 21, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05707480036233 12 05707480020782 In Commercial Distribution
05707480020782 20 05707480032372 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
CLOSE