VitalPatch™ 2.0 Single 3035-01

GUDID 00850490007214

VitalPatch 2.0 Single

Vital Connect, Inc.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00850490007214
• NIH Device Record Key: 79788e5f-7be5-4efa-a209-28b14ac2b03e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalPatch™ 2.0 Single
• Version Model Number: 3035-01
• Catalog Number: 3035-01
• Company DUNS: 944642730
• Company Name: Vital Connect, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850490007214 [Primary]
GS1	00850490007221 [Package]; Package: Box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183078

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-26
• Device Publish Date: 2019-03-18

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