DEVICE: aScope™ 3 Large 5.8/2.8Flexible Videoscope - Single Use (05707480133109)

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Device Identifier (DI) Information

aScope™ 3 Large 5.8/2.8Flexible Videoscope - Single Use
414001000
414001000
Ambu A/S
05707480133109
GS1
1
Ambu aScope 3 Large 5.8/2.8 Single-use flexible scope with insertion cord diameter of 5.8 mm and channel width up to 2.8 mm. Min. purchase is 5 pcs. = 1 box
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Device Characteristics

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

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
Flexible video bronchoscope, single-use A sterile endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is commonly intended for flexible optical intubation, airway inspection, and may assist other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
EOQ BRONCHOSCOPE (FLEXIBLE OR RIGID)
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Sterilization

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

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Storage and Handling
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Lumen/Inner Diameter: 2.8 Millimeter
Outer Diameter: 5.8 Millimeter
Device Size Text, specify: Size 3
Length: 600 Millimeter
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Device Status

In Commercial Distribution
September 21, 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
05707480133116 5 05707480133109 In Commercial Distribution
05707480133123 4 05707480133116 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

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+14107686464
Purchase_orders@ambuUSA.com
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