DEVICE: aScope™ 4 Broncho Regular 5.0/2.2Flexible Endoscope - Single Use (05707480135509)
Device Identifier (DI) Information
aScope™ 4 Broncho Regular 5.0/2.2Flexible Endoscope - Single Use
477001000
In Commercial Distribution
477001000
Ambu A/S
477001000
In Commercial Distribution
477001000
Ambu A/S
Ambu aScope 4 Broncho Regular 5.0/2.2 Single-use and flexible brochoscope. Portable and sterile from the pack. Suitable for intubation, Airway inspection,tube check, BAL & BW procedures, PDT procedures Bending section: 180° up/180° down Insert cord diameter: 5.5 mm, working lenght: 600 mm Minimum purchase is 5 pcs = 1 box
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
Yes | |
No | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60963 | Flexible video bronchoscope, single-use |
An 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 typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EOQ | Bronchoscope (flexible or rigid) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 5 Millimeter |
Lumen/Inner Diameter: 2.2 Millimeter |
Length: 600 Millimeter |
Device Size Text, specify: Size 4 |
Device Record Status
7d48193b-3592-4605-b6c8-fc34dcf98f18
February 03, 2023
3
July 04, 2018
February 03, 2023
3
July 04, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05707480135523 | 4 | 05707480135516 | In Commercial Distribution | ||
05707480135516 | 5 | 05707480135509 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+14107686464
Purchase_orders@ambuUSA.com
Purchase_orders@ambuUSA.com