aScope™ 4 RhinoLaryngo Intervention

Basic Information

• Brand Name: aScope™ 4 RhinoLaryngo Intervention
• Primary DI: 05707480136971
• Version / Model: 512001000
• Catalog Number: 512001000
• Company Name: Ambu A/S
• Labeler DUNS: 305682023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-06
• Public Version: 2
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: 86b0853f-ae0b-4232-93e4-4ae813d9068a

Device Description

Ambu aScope 4 RhinoLaryngo Intervention Single-use, flexible Rhinolaryngoscope Sterile from package. 2.2 mm working channel, outer diameter 5.0 mm, lenght of 350 mm. and a 130-degree bending angle. Minimum purchase 5 pcs = 1 box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOB	Nasopharyngoscope (flexible or rigid)	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63330	Flexible video otorhinolaryngoscope, single-use	An endoscope with a flexible inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480136988	GS1		5	In Commercial Distribution
Primary	05707480136971	GS1
Package	05707480136964	GS1		4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	2	Millimeter
Outer Diameter	5	Millimeter
Length	350	Millimeter
Device Size Text, specify			Size 4

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius