Dual Tab Electrode 292-DTE

GUDID B277292DTE1

Lymphederma Dual Tab Electrodes; each pouch contains 60 single use gel backed electrodes

IMPEDIMED LIMITED

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use

• Primary Device ID: B277292DTE1
• NIH Device Record Key: 982743cb-1d52-467e-8ded-83c5ab7c5ba4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Tab Electrode
• Version Model Number: 292-DTE
• Catalog Number: 292-DTE
• Company DUNS: 757258843
• Company Name: IMPEDIMED LIMITED
• Device Count: 60
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +61738603700
• Email: XX@XX.com
• Phone: +61738603700
• Email: XX@XX.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B277292DTE08 [Unit of Use]
HIBCC	B277292DTE1 [Primary]
HIBCC	B277292DTE2 [Package]; Package: shipper [10 Units]

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-13

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