KENTEK BLUE SONIC

GUDID 00810003754271

KENTEK BLUE SONIC WET GEL EKG ELECTRODES

KENTRON HEALTHCARE, INC.

Electrocardiographic electrode, single-use

• Primary Device ID: 00810003754271
• NIH Device Record Key: 26fce741-62f0-49ec-92be-1a375af9bc1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KENTEK BLUE SONIC
• Version Model Number: KBS22
• Company DUNS: 618825723
• Company Name: KENTRON HEALTHCARE, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810003754264 [Primary]
GS1	00810003754271 [Package]; Contains: 00810003754264; Package: PACK [50 Units]; In Commercial Distribution
GS1	00810003754288 [Package]; Package: CASE [40 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2024-02-26
• Device Publish Date: 2024-02-18

Devices Manufactured by KENTRON HEALTHCARE, INC.

• 10810003751031 - KENOREX: 2024-04-22 NASOPHARYNGEAL AIRWAY ROBERTAZZI STYLE 12 FR
• 10810003751048 - KENOREX: 2024-04-22 NASOPHARYNGEAL AIRWAY ROBERTAZZI STYLE 14 FR
• 10810003751055 - KENOREX: 2024-04-22 NASOPHARYNGEAL AIRWAY ROBERTAZZI STYLE 16 FR
• 10810003751062 - KENOREX: 2024-04-22 NASOPHARYNGEAL AIRWAY ROBERTAZZI STYLE 18 FR
• 10810003751079 - KENOREX: 2024-04-22 NASOPHARYNGEAL AIRWAY ROBERTAZZI STYLE 20 FR
• 10810003751086 - KENOREX: 2024-04-22 NASOPHARNGEAL AIRWAY ROBERTAZZI STYLE 22 FR
• 10810003751093 - KENOREX: 2024-04-22 NASOPHARYNGEAL AIRWAY ROBERTAZZI STYLE 24 FR
• 10810003751109 - KENOREX: 2024-04-22 NASOPHARYNGEAL AIRWAY ROBERTAZZI STYLE 26 FR