DEVICE: Reusable PEEP 20 valve (05707480029686)

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Device Identifier (DI) Information

Reusable PEEP 20 valve
A000213000
A000213000
Ambu A/S
05707480029686
GS1
1
Ambu PEEP valve 20,range 1.5 - 20 mbar, non-calibrated, with connector, ID 30 mm (with die-stamped caution)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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GMDN

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

GMDN Preferred Term Name GMDN Definition
PEEP valve, reusable A non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
BYE Attachment, breathing, positive end expiratory pressure
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Temperature: between -20 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 65 Millimeter
Weight: 40 Gram
Outer Diameter: 45 Millimeter
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Device Status

In Commercial Distribution
January 07, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05707480015078 40 05707480029686 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
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No CLOSE

Customer Contact

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+14107686464
Purchase_orders@ambuUSA.com
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