Butterfly Network, Inc.

GUDID 00866646000206

Portable Ultrasound System

BUTTERFLY NETWORK, INC.

General-purpose ultrasound imaging system

• Primary Device ID: 00866646000206
• NIH Device Record Key: 05f5f3b5-1366-4fc9-b7e0-cbd4c93f4764
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Butterfly Network, Inc.
• Version Model Number: Butterfly iQ
• Company DUNS: 064617010
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)296-6188
• Email: bsawin@butterflynetwork.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866646000206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163510

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

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: 2018-09-10
• Device Publish Date: 2018-08-10

Devices Manufactured by BUTTERFLY NETWORK, INC.

• 00850027593036 - BUTTERFLY IQ3 ACCESSORY CABLE, LIGHTNING C78, USB2.0, 1.50M: 2024-02-22
• 00850027593043 - BUTTERFLY IQ3 ACCESSORY CABLE, LIGHTNING C78, USB2.0, 2.50M: 2024-02-22
• 00850027593050 - BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 1.50M: 2024-02-22
• 00850027593067 - BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 2.50M: 2024-02-22
• 00850027593074 - Butterfly iQ3 Charger Kit: 2024-02-22
• 00850027593005 - LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter: 2021-03-18 LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter
• 00850027593012 - USB-C CABLE ASSEMBLY, USB 2.0, 2.50 meter: 2021-03-18 USB-C CABLE ASSEMBLY, USB 2.0, 2.50 meter
• 00866646000275 - LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter: 2020-12-29 LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter