Philips Wearable Biosensor 989803200061

GUDID 20884838085231

Philips Medical Systems

Electrocardiography telemetric monitoring system

• Primary Device ID: 20884838085231
• NIH Device Record Key: 4c9488ed-138d-40b5-8b04-619d6b6e2c3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Philips Wearable Biosensor
• Version Model Number: 989803200061
• Catalog Number: 989803200061
• Company DUNS: 078628040
• Company Name: Philips Medical Systems
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
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Device Identifiers

Device Issuing Agency	Device ID
GS1	20884838085231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152139

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: 2
• Public Version Date: 2018-07-23
• Device Publish Date: 2018-06-14

On-Brand Devices [Philips Wearable Biosensor]

• 20884838085231: 989803200061
• 20884838064960: 989803196871
• 20884838064953: 989803196861