Ambu 10-510177-1

GUDID 20818634025139

Ambu aScope 4 RhinoLaryngo Slim 5/Box

Bosma Enterprises

Flexible video otorhinolaryngoscope, single-use

• Primary Device ID: 20818634025139
• NIH Device Record Key: 8bdfcb14-f272-45c9-84a5-08a1a719ad8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ambu
• Version Model Number: 10-510177-1
• Catalog Number: 10-510177-1
• Company DUNS: 878070325
• Company Name: Bosma Enterprises
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org
• Phone: 800-362-5463
• Email: kimm@bosma.org

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818634025135 [Unit of Use]
GS1	10818634025132 [Primary]
GS1	20818634025139 [Package]; Contains: 10818634025132; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• EOB: Nasopharyngoscope (Flexible Or Rigid)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-09
• Device Publish Date: 2023-05-01

On-Brand Devices [Ambu]

• 20818634025191: Ambu aScope 4 Cysto Reverse Deflection 5/Box
• 20818634025160: Ambu aScope 4 Broncho Regular 5.0/2.2 5/Box
• 20818634025153: AMBU aScope 4 Broncho Slim 3.8/1.2 5/Box
• 20818634025146: Ambu aScope 4 Cysto 5/Box
• 20818634025139: Ambu aScope 4 RhinoLaryngo Slim 5/Box
• 20818634025115: Ambu aScope 4 Broncho Large 5.8/2.8 5/Box