AccessGUDID - DEVICE: MADSEN Astera 2 (05713315007477)

GUDID

Device Identifier (DI) Information

Brand Name: MADSEN Astera 2
Version or Model: 8-04-12118
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8-04-12118
Company Name: Natus Medical Denmark ApS

Primary DI Number: 05713315007477
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306633756 *Terms of Use

Device Description: 1066 MADSEN Astera 2 without ACP ANSI Cal.Incl. ME70 Headset, Insert Earphone, BC-1 BC

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:	No
Prescription Use (Rx):	Yes
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?
41188	Speech audiometer	An electroacoustic device designed to measure the hearing threshold of a patient by presenting words of increasing or decreasing intensity through headphones, which the patient is required to recognize and repeat, to establish the hearing capacity of the patient and to determine if a hearing deficit exists.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWO	Audiometer

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: abf43acb-9288-4fc9-b37f-052e629eba58
Public Version Date: April 18, 2025
Public Version Number: 2
DI Record Publish Date: December 12, 2024