LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter

GUDID 00866646000244

LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter

BUTTERFLY NETWORK, INC.

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 00866646000244
• NIH Device Record Key: c480f9b3-eda4-4d81-a8e3-a5d0c81f5f7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter
• Version Model Number: 490-00183-00, 490-00189-00
• 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: true
• Serial Number: false
• 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@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com
• Phone: +1(855)296-6188
• Email: bsawin@butterflynetinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866646000244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163510

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: 2020-10-07
• Device Publish Date: 2020-09-29

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