FDA.reportPublic FDA data

LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter

Primary DI
00850027593005
Brand
LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter
Company
Butterfly Network, Inc.
Model
490-00189-03
Device description
LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter
Published
2021-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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

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
00850027593005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850027593005008500275930058500275930050850027593005

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.

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
true
Serial number
false
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
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
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

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Primary DI, Brand, Company table
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