Sanibel Supply A/S

Basic Information

• Brand Name: Sanibel Supply A/S
• Primary DI: 05711117221053
• Version / Model: Infant EarCupTM Hydrogel
• Catalog Number: 8522011 (2 pcs)
• Company Name: Interacoustics A/S
• Labeler DUNS: 306308354
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-11-29
• Public Version: 1
• Public Version Date: 2022-12-07
• Public Version Status: New
• Public Device Record Key: a490920e-1f82-4697-acda-1bae73340d84

Device Description

Circumaural Coupler

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETT	Cushion, Earphone (For Audiometric Testing)	Ear, Nose, Throat	874.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31940	Earphone cushion	A device that is part of an earphone, sometimes detachable, which rests against the ear or head. In the case of audiometric ear phones the cushion is part of the specification for calibration purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05711117217704	GS1		20	In Commercial Distribution
Primary	05711117221053	GS1
Unit of Use	05711117221039	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 27 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 41 – 80 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight