Irregular Rhythm Notification feature 2.0

GUDID 00194252456781

Irregular Rhythm Notification feature iPhone App (Version 2.0)

APPLE INC.

Self-care monitoring/reporting software

• Primary Device ID: 00194252456781
• NIH Device Record Key: fe8f35cc-4f0c-416d-b9a8-f7cf92bdcf44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Irregular Rhythm Notification feature 2.0
• Version Model Number: Feature Version 2.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	00194252456781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212516

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: 2022-03-22
• Device Publish Date: 2022-03-14

On-Brand Devices [Irregular Rhythm Notification feature 2.0]

• 00194252456781: Irregular Rhythm Notification feature iPhone App (Version 2.0)
• 00194252456774: Irregular Rhythm Notification feature Watch App (Version 2.0)