Atrial Fibrillation History Feature

GUDID 00194252456804

Atrial Fibrillation History Feature Watch app

APPLE INC.

Self-care monitoring/reporting software

• Primary Device ID: 00194252456804
• NIH Device Record Key: 7f87bee0-7ad3-4e74-a832-1f0dca0b66f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atrial Fibrillation History Feature
• Version Model Number: Feature version 1.x
• Company DUNS: 060704780
• Company Name: APPLE 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00194252456804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213971

FDA Product Code

• QDB: Photoplethysmograph Analysis Software For Over-The-Counter Use

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: 2022-09-20
• Device Publish Date: 2022-09-12

On-Brand Devices [Atrial Fibrillation History Feature]

• 00194252456804: Atrial Fibrillation History Feature Watch app
• 00194252456798: Atrial Fibrillation History Feature iPhone app