TruTone EMOTE® Electrolarynx

GUDID 00813124010196

GRIFFIN LABORATORIES

Transcervical artificial larynx

• Primary Device ID: 00813124010196
• NIH Device Record Key: 6ea3e6f9-5a2e-4f0d-ad76-13d79e77294f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruTone EMOTE® Electrolarynx
• Version Model Number: K1300
• Company DUNS: 016865375
• Company Name: GRIFFIN LABORATORIES
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813124010196 [Primary]

FDA Product Code

• ESE: Larynx, Artificial (Battery-Powered)

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: 2019-10-31
• Device Publish Date: 2019-10-23

On-Brand Devices [TruTone EMOTE® Electrolarynx]

• 00813124010387: KD1000
• 00813124010325: K1052
• 00813124010196: K1300
• 00813124010189: K1000-CAN
• 00813124010158: 7439
• 00813124010141: K1000