ECG Leadwires

GUDID 06941691938194

Philips Compatible, 3-Lead, Grabber End, AHA, 0.9m

Orantech Inc.

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• Primary Device ID: 06941691938194
• NIH Device Record Key: d0f653b4-b718-44fa-8e32-bfed59d64e58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Leadwires
• Version Model Number: EL-AA3-90G-A
• Company DUNS: 544423370
• Company Name: Orantech 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06941691938194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182327

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2021-01-04
• Device Publish Date: 2020-12-25

On-Brand Devices [ECG Leadwires]

• 06941691940074: GE Marquette Compatible, 5-Lead, Grabber End, AHA, 0.9m
• 06941691940012: Philips Compatible, 5-Lead, Snap End, AHA, 0.9m
• 06941691938194: Philips Compatible, 3-Lead, Grabber End, AHA, 0.9m