Telemetry Transmitter

GUDID 06944413802278

Edan Instruments, Inc.

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 06944413802278
• NIH Device Record Key: 86ff7801-64ce-4133-8e40-d6926a072a2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Telemetry Transmitter
• Version Model Number: iT20
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413802261 [Primary]
GS1	06944413802278 [Package]; Contains: 06944413802261; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161056

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-02-22

Devices Manufactured by Edan Instruments, Inc.

• 06944413820463 - Holter ECG and ABP System: 2023-12-08
• 06944413820470 - Holter ECG and ABP System: 2023-12-08
• 06944413820487 - Holter ECG and ABP System: 2023-12-08
• 06944413820494 - Holter ECG and ABP System: 2023-12-08
• 06944413820500 - Holter ECG and ABP System: 2023-12-08
• 06944413820562 - Electrocardiograph: 2023-12-08
• 06944413820616 - Electrocardiograph: 2023-12-08
• 06944413812680 - Ambulatory Blood Pressure Monitor: 2023-06-29