Butterfly iQ+ Bladder Ultrasound System

GUDID 00850027593081

Butterfly Network, Inc.

Hand-held ultrasound imaging system, body-surface
Primary Device ID00850027593081
NIH Device Record Key8c02bad2-e094-46b0-9d1f-33924d9768b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameButterfly iQ+ Bladder Ultrasound System
Version Model Number850-20028
Company DUNS117520495
Company NameButterfly Network, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850027593081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-23
Device Publish Date2024-05-15

Devices Manufactured by Butterfly Network, Inc.

00850027593111 - BUTTERFLY MOBILE DEVICE CHARGING KIT2024-09-19
00850027593128 - Butterfly iQ3 Charger Kit2024-09-12
00850027593081 - Butterfly iQ+ Bladder Ultrasound System2024-05-23
00850027593081 - Butterfly iQ+ Bladder Ultrasound System2024-05-23
00850027593036 - BUTTERFLY IQ3 ACCESSORY CABLE, LIGHTNING C78, USB2.0, 1.50M2024-02-22
00850027593043 - BUTTERFLY IQ3 ACCESSORY CABLE, LIGHTNING C78, USB2.0, 2.50M2024-02-22
00850027593050 - BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 1.50M2024-02-22
00850027593067 - BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 2.50M2024-02-22
00850027593074 - Butterfly iQ3 Charger Kit2024-02-22

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