ECG Lead Set 989803128971

GUDID 00884838021938

Philips Medical Systems

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• Primary Device ID: 00884838021938
• NIH Device Record Key: d557a3ad-8eac-4a61-85a7-6a1e1ae2eddc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG Lead Set
• Version Model Number: 989803128971
• Catalog Number: 989803128971
• Company DUNS: 078628040
• Company Name: Philips Medical Systems
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838021938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031187

FDA Product Code

• DRO: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

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: 2018-07-06
• Device Publish Date: 2017-04-04

On-Brand Devices [ECG Lead Set]

• 00884838028326: 989803176181
• 00884838021938: 989803128971