Butterfly iQ3 Charger Kit

GUDID 00850027593128

Butterfly Network, Inc.

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 00850027593128
• NIH Device Record Key: 658ba603-ad03-47fc-99e7-4d21c1447db5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Butterfly iQ3 Charger Kit
• Version Model Number: 815-20054-01
• Company DUNS: 117520495
• Company Name: Butterfly Network, 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027593128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232808

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

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: 2024-09-12
• Device Publish Date: 2024-09-04

On-Brand Devices [Butterfly iQ3 Charger Kit]

• 00850027593074: 815-20054-00
• 00850027593128: 815-20054-01