AccessGUDID - DEVICE: BAHA FITTING SOFTWARE 5 CD (09321502074117)

GUDID

Device Identifier (DI) Information

Brand Name: BAHA FITTING SOFTWARE 5 CD
Version or Model: P803255CD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Cochlear Americas Corporation

Primary DI Number: 09321502074117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 130866817 *Terms of Use

Device Description: No description.

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":	No
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?
57884	Hearing aid wireless-fitting computer-aided set	A collection of devices designed to work in conjunction with a computer to transmit wireless data to a hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by healthcare personnel. It primarily consists of computer application software and a neck loop to establish the wireless link (the radio link protocol) with the hearing aid. The hearing aid must be compatible for wireless data reception and may be behind-the-ear (BTE), in-the-ear (ITE) and completely-in-the-canal (CIC) types.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXB	Hearing aid, bone conduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132278	000

Device Exempt from Premarket Submission: No 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: 75667141-95d1-40aa-ace8-2c8b6258ba89
Public Version Date: January 11, 2024
Public Version Number: 1
DI Record Publish Date: January 03, 2024