| Primary Device ID | 00850027593135 |
| NIH Device Record Key | e537ea5a-d5c6-4a65-aeb7-77c0be7b1746 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Butterfly iQ3 Ultrasound System |
| Version Model Number | 850-20033 |
| Company DUNS | 117520495 |
| Company Name | Butterfly Network, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850027593135 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-18 |
| Device Publish Date | 2025-12-10 |
| 00850027593135 - Butterfly iQ3 Ultrasound System | 2025-12-18 |
| 00850027593135 - Butterfly iQ3 Ultrasound System | 2025-12-18 |
| 00850027593111 - BUTTERFLY MOBILE DEVICE CHARGING KIT | 2024-09-19 |
| 00850027593128 - Butterfly iQ3 Charger Kit | 2024-09-12 |
| 00850027593081 - Butterfly iQ+ Bladder Ultrasound System | 2024-05-23 |
| 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 |