FDA.reportPublic FDA data

Butterfly Network, Inc.

Primary DI
00866646000206
Brand
Butterfly Network, Inc.
Company
Butterfly Network, Inc.
Model
Butterfly iQ
Device description
Portable Ultrasound System
Published
2018-08-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITXTransducer, ultrasonic, diagnostic
IYNSystem, imaging, pulsed doppler, ultrasonic
IYOSystem, imaging, pulsed echo, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866646000206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866646000206008666460002068666460002060866646000206

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Regulatory Flags#

DUNS number
117520495
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850027593005LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter490-00189-032021-03-10
00850027593012USB-C CABLE ASSEMBLY, USB 2.0, 2.50 meter490-00187-032021-03-10
00866646000275LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter490-00183-02, 490-00189-022020-12-21
00866646000213BUTTERFLY iQ+850-200142020-09-29
00866646000220USB-C CABLE ASSEMBLY, USB 2.0, 1.25 meter490-00187-002020-09-29
00866646000237USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter490-00187-012020-09-29
00866646000244LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter490-00183-00, 490-00189-002020-09-29
00866646000251LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter490-00183-01, 490-00189-012020-09-29
00866646000268BUTTERFLY iQ/iQ+ WIRELESS CHARGER KITWTD1A052020-09-29
00866646000282USB-C CABLE ASSEMBLY, USB 2.0, 1.50 meter490-00187-022020-09-29
00866646000299USB-C CABLE ASSEMBLY, USB 3.1 GEN 1, 1.50 meter490-00192-022020-09-29
00866646000305LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter490-00183-02, 490-00189-022020-09-29
00850027593135Butterfly iQ3 Ultrasound System850-200332025-12-10
00850027593081Butterfly iQ+ Bladder Ultrasound System850-200282024-05-15
00850027593111BUTTERFLY MOBILE DEVICE CHARGING KIT815-20072-002024-09-11
00850027593128Butterfly iQ3 Charger Kit815-20054-012024-09-04
00850027593036BUTTERFLY IQ3 ACCESSORY CABLE, LIGHTNING C78, USB2.0, 1.50M490-00227-022024-02-14
00850027593043BUTTERFLY IQ3 ACCESSORY CABLE, LIGHTNING C78, USB2.0, 2.50M490-00227-032024-02-14
00850027593050BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 1.50M490-00228-022024-02-14
00850027593067BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 2.50M490-00228-032024-02-14

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Primary DI, Brand, Company table
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