FDA.reportPublic FDA data

LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter

Primary DI
00866646000244
Brand
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter
Company
BUTTERFLY NETWORK, INC.
Model
490-00183-00, 490-00189-00
Device description
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter
Published
2020-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163510000Poseidon Ultrasound SystemButterfly Network, Inc.2017-09-06IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866646000244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866646000244008666460002448666460002440866646000244

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held ultrasound imaging system, body-surfaceA battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addition be intended to be used with a sterile cover for intraoperative imaging. It consists of a flat- or concave-lensed ultrasound transducer and includes an integrated image processing system; it may include an integrated display or be intended to wirelessly transmit images to an off-the-shelf device (e.g., smartphone, tablet) with dedicated software installed. It is not designed to be inserted into the vagina or rectum.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)296-6188bsawin@butterflynetinc.com

Regulatory Flags#

DUNS number
064617010
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866646000206Butterfly Network, Inc.Butterfly iQ2018-08-10
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
00850027593074Butterfly iQ3 Charger Kit815-20054-002024-02-14
00850027593029Butterfly iQ3 Ultrasound System850-200262024-02-13
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
00866646000305LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter490-00183-02, 490-00189-022020-09-29
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
00866646000251LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter490-00183-01, 490-00189-012020-09-29
00866646000268BUTTERFLY iQ/iQ+ WIRELESS CHARGER KITWTD1A052020-09-29

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