AccessGUDID - DEVICE: AMPLIFON (00840388205730)

GUDID

Device Identifier (DI) Information

Brand Name: AMPLIFON
Version or Model: AMPLI-TV 2.0 LE ST
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STARKEY LABORATORIES, INC.

Primary DI Number: 00840388205730
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055461479 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
41243	Television set listening aid	A device used by a person that is hard of hearing to listen to a television (TV) set. It takes the sound output from a TV, either by a direct electrical connection or by means of a microphone placed close to the TV loudspeaker, amplifies the signal which is then fed to the user by means of an earphone or an induction loop in conjunction with an appropriate hearing aid.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSM	Hearing Aid, Air-Conduction with Wireless Technology, Prescription

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 -40 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: defe0c6f-f523-4deb-8c63-1359c969de75
Public Version Date: December 09, 2024
Public Version Number: 1
DI Record Publish Date: November 29, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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