2107243-006

GUDID 00840682140492

GE Healthcare Finland Oy

Electrocardiographic lead set, reusable

• Primary Device ID: 00840682140492
• NIH Device Record Key: d9b84408-30b2-4e67-83c6-c55559872ee2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ECG Leadwire set, telemetry, 3-lead, snap, AHA, 27
• Catalog Number: 2107243-006
• Company DUNS: 401966697
• Company Name: GE Healthcare Finland Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00840682140492 [Primary]

FDA Product Code

• IKD: CABLE, ELECTRODE

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: 2019-03-08
• Device Publish Date: 2019-02-05

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• 00195278229229 - PORTRAIT RRP01: 2024-01-03 BODY-WORN RESP ELECTRODE PATCH
• 00195278699916 - PORTRAIT AAB01: 2023-11-03 Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS