AccessGUDID - DEVICE: BC-1 (09120041051661)

GUDID

Device Identifier (DI) Information

Brand Name: BC-1
Version or Model: BC-1-BONE-W-HEADBAND/GR7024
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 77735155
Company Name: BHM-Tech Produktionsgesellschaft m.b.H.

Primary DI Number: 09120041051661
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300632705 *Terms of Use

Device Description: Audiometric receiver with headband

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):	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?
35619	Auditory cranial bone vibrator	An electromechanical transducer intended to produce the sensation of hearing by vibrating the cranial bones. It can be used as an output device with an audiometer to measure bone-conduction hearing thresholds, and thus serve as an adjunct to air-conduction testing with conventional earphones. Comparison of the results enables the clinician to distinguish hearing loss attributable to the external or middle ear (conductive loss) from the inner ear (sensory loss). In addition, this device may be used to provide output for a hearing aid for patients who cannot wear an earmould.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXB	Hearing Aid, Bone Conduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102199	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
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53e7c8ea-38a0-4da9-81d5-d26748fa33aa
Public Version Date: October 06, 2020
Public Version Number: 3
DI Record Publish Date: May 24, 2018