Accessory Box AB04 (Auditdata)

Basic Information

• Brand Name: Accessory Box AB04 (Auditdata)
• Primary DI: 04260223142826
• Version / Model: 100587-AD
• Company Name: PATH medical GmbH
• Labeler DUNS: 551540334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-26
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1d23ee89-b34c-4224-abf4-792eb2d793cc

Device Description

Accessory box for Tymp probe Content: 1. Transparent Lurex Box 11 compartments. AN100336 2. Probe Tip 'Adult' for Children & Adults. AN100013 3. Probe Tip 'Small' for Babies. AN100014-W 4. Test cavity for EP-DP and EP-TE with Ear Probe Tip A. AN100129 5. Ear tip ET-03 5 mm. AN100063 6. Ear tip Lamella 6-10mm, blue. AN100064 7. Ear Tip, Lamella 8-11mm. AN100144 8. Ear tip ET-11 Lamella 12-16mm. AN100125 9. EarTip Soft ET-16 10mm. AN100838 10. Ear tip Soft ET-17 14 mm. AN100839 11. EarTip ET-20 14mm mushroom. AN100576 12. EarTip ET-21 18mm mushroom. AN100577 13. Cleaning tool. AN100151

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWJ	Stimulator, Auditory, Evoked Response	Neurology	882.1900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35747	Evoked-potential audiometer	An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260223142826	GS1