Disposable Pressure ManometerSingle Patient Use 322004000

GUDID 05707480036233

Manometer - 20PCS/BOX, 12BOXES/T30BOX US

Ambu A/S

Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered Airway pressure monitor, non-powered
Primary Device ID05707480036233
NIH Device Record Key1d2f6b3d-710c-4930-8937-6a60b6b8258e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Pressure ManometerSingle Patient Use
Version Model Number322004000
Catalog Number322004000
Company DUNS305682023
Company NameAmbu A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com
Phone+14107686464
EmailPurchase_orders@ambuUSA.com

Device Dimensions

Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter
Weight6.4 Gram
Length55 Millimeter
Outer Diameter22 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -18 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105707480020782 [Package]
Contains: 05707480032372
Package: [20 Units]
In Commercial Distribution
GS105707480032372 [Primary]
GS105707480036233 [Package]
Contains: 05707480020782
Package: [12 Units]
In Commercial Distribution

FDA Product Code

CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-21

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