DEVICE: Ambu Cuff Pressure Gauge (05707480133079)

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Device Identifier (DI) Information

Ambu Cuff Pressure Gauge
321900000
321900000
Ambu A/S
05707480133079
GS1
1
Ambu Cuff Pressure Gauge, for inflating and testing cuffs Tube length 100 cm, luer type connection
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
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
Endotracheal tube cuff inflator A device designed to instill air into the cuff of an in situ endotracheal (ET)/endobronchial tube. The inflator typically includes a manually-operated rubber bulb for the delivery of ambient air into the cuff, and a pressure gauge or manometer that displays the pressure within the cuff to help prevent the development of excessive pressure which may cause trauma to the trachea. The purpose of the cuff is to provide an adequate seal for positive pressure ventilation and to prevent aspirated secretions from passing into the lungs. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
BSK Cuff, tracheal tube, inflatable
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 20, 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
05707480133086 42 05707480133079 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
Yes
No
No CLOSE

Customer Contact

[?]
+14107686464
Purchase_orders@ambuUSA.com
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