AccessGUDID - DEVICE: Sanibel Supply A/S (05711117221053)

GUDID

Device Identifier (DI) Information

Brand Name: Sanibel Supply A/S
Version or Model: Infant EarCupTM Hydrogel
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8522011 (2 pcs)
Company Name: Interacoustics A/S

Primary DI Number: 05711117221053
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 306308354 *Terms of Use

Device Description: Circumaural Coupler

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETT	Cushion, Earphone (For Audiometric Testing)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 27 Degrees Celsius
Storage Environment Temperature: between 41 and 80 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a490920e-1f82-4697-acda-1bae73340d84
Public Version Date: December 07, 2022
Public Version Number: 1
DI Record Publish Date: November 29, 2022