AMPLIFON

GUDID 00840388203767

STARKEY LABORATORIES, INC.

Tinnitus masking application software

• Primary Device ID: 00840388203767
• NIH Device Record Key: 0a2b31fa-2902-4dd5-b5fa-a247b79c1ada
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMPLIFON
• Version Model Number: AMPLIFON AMPLI-ENERGY R 4|6S R-S ST
• Company DUNS: 055461479
• Company Name: STARKEY LABORATORIES, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840388203767 [Primary]

FDA Product Code

• KLW: Masker, tinnitus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-09
• Device Publish Date: 2024-11-29

On-Brand Devices [AMPLIFON]

• 00842318189165: AMPLI-CHARGE I 1 ST
• 00842318189158: AMPLI-CHARGE B/R 1 ST
• 00842318189141: AMPLI-CHARGE
• 00842318189134: AMPLI-TV ST
• 00842318189127: AMPLIFON AMPLI-MINI I 3 TH 10 IIC NWL
• 00842318189110: AMPLIFON AMPLI-MINI I 4 TH 10 IIC NWL
• 00842318189103: AMPLIFON AMPLI-MINI I 5 TH 10 IIC NWL
• 00842318189097: AMPLIFON AMPLI-MINI I 3 TH 10 NWL
• 00842318189080: AMPLIFON AMPLI-MINI I 4 TH 10 NWL
• 00842318189073: AMPLIFON AMPLI-MINI I 5 TH 10 NWL
• 00842318189066: AMPLIFON AMPLI-MINI I 2 TH 312 WL
• 00842318189059: AMPLIFON AMPLI-MINI I 3 TH 312 WL
• 00842318189042: AMPLIFON AMPLI-MINI I 4 TH 312 WL
• 00842318189035: AMPLIFON AMPLI-MINI I 5 TH 312 WL
• 00842318189028: AMPLIFON AMPLI-ENERGY I 3 TH R ITC WL
• 00842318189011: AMPLIFON AMPLI-ENERGY I 4 TH R ITC WL
• 00842318189004: AMPLIFON AMPLI-ENERGY I 5 TH R ITC WL
• 00842318188991: AMPLIFON AMPLI-ENERGY R 3 TH R
• 00842318188984: AMPLIFON AMPLI-ENERGY R 4 TH R
• 00842318188977: AMPLIFON AMPLI-ENERGY R 5 TH R
• 00842318188960: AMPLIFON AMPLI-ENERGY B 3 TH R-P
• 00842318188953: AMPLIFON AMPLI-ENERGY B 4 TH R-P
• 00842318188946: AMPLIFON AMPLI-ENERGY B 5 TH R-P
• 00842318188939: AMPLIFON AMPLI-EASY B 2 TH 13-SP
• 00842318188922: AMPLIFON AMPLI-CONNECT B 3 TH 13-SP
• 00842318188915: AMPLIFON AMPLI-CONNECT B 4 TH 13-SP
• 00842318188908: AMPLIFON AMPLI-CONNECT B 5 TH 13-SP
• 00840388206201: AMPLIFON AMPLI-ENERGY R 5|6S R ST (TIER DEMO)
• 00840388206195: AMPLIFON AMPLI-ENERGY R 5|6S R ST (DEMO)
• 00840388205730: AMPLI-TV 2.0 LE ST
• 00840388205631: AMPLIFON AMPLI-ENERGY I 2|6S R HS WL ST
• 00840388205570: AMPLIFON AMPLI-ENERGY I 3|6S R HS WL ST
• 00840388205518: AMPLIFON AMPLI-ENERGY I 4|6S R HS WL ST
• 00840388205457: AMPLIFON AMPLI-ENERGY I 5|6S R HS WL ST
• 00840388205389: AMPLIFON AMPLI-ENERGY I 2|6S R ITC WL ST
• 00840388205303: AMPLIFON AMPLI-ENERGY I 3|6S R ITC WL ST
• 00840388205228: AMPLIFON AMPLI-ENERGY I 4|6S R ITC WL ST
• 00840388205143: AMPLIFON AMPLI-ENERGY I 5|6S R ITC WL ST
• 00840388205075: AMPLIFON AMPLI-ENERGY I 2|6S R ITE WL ST
• 00840388205006: AMPLIFON AMPLI-ENERGY I 3|6S R ITE WL ST
• 00840388204931: AMPLIFON AMPLI-ENERGY I 4|6S R ITE WL ST
• 00840388204863: AMPLIFON AMPLI-ENERGY I 5|6S R ITE WL ST
• 00840388204771: AMPLIFON AMPLI-MINI I 2|6S 312 CIC WL ST
• 00840388204665: AMPLIFON AMPLI-MINI I 3|6S 312 CIC WL ST
• 00840388204573: AMPLIFON AMPLI-MINI I 4|6S 312 CIC WL ST
• 00840388204481: AMPLIFON AMPLI-MINI I 5|6S 312 CIC WL ST
• 00840388204429: AMPLIFON AMPLI-CONNECT R 3|6S 312 ST
• 00840388204306: AMPLIFON AMPLI-CONNECT R 4|6S 312 ST
• 00840388204214: AMPLIFON AMPLI-CONNECT R|6S 312 ST (TIER DEMO)
• 00840388204122: AMPLIFON AMPLI-CONNECT R 5|6S 312 ST (DEMO)