Transonic

GUDID 00877466000406

TRANSONIC SYSTEMS INC.

Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered Noninvasive vascular ultrasound system, line-powered
Primary Device ID00877466000406
NIH Device Record Keycbabc6a1-8888-4181-ab29-c9cda543312b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransonic
Version Model NumberH9FX
Company DUNS101317451
Company NameTRANSONIC SYSTEMS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100877466000406 [Primary]
GS100877466000406 [Primary]
GS100877466000406 [Primary]
GS100877466000406 [Primary]
GS100877466000406 [Primary]
GS100877466000406 [Primary]
GS100877466000406 [Primary]
GS100877466000406 [Primary]
GS100877466000406 [Primary]
GS100877466000406 [Primary]
GS100877466000406 [Primary]
GS100877466000406 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function
DXGComputer, Diagnostic, Pre-Programmed, Single-Function

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-09
Device Publish Date2020-10-01

On-Brand Devices [Transonic]

00877466001531HQC2FMC
08774660001531HQC2FMC
00877466000130HT364
00877466002080HQC8FMV
00877466000895HQD7XL
00877466000543ABLPHR
00877466000536ABLPHI
00877466000529ABLPHE
00877466000512ABLPHDI
00877466000505BLF22A
00877466000499BLF22
00877466000482BLF21
00877466005791ADT1010-40
00877466000451H4FX
00877466000437HD03
00877466000413HFW1000
00877466000406H9FX
00877466000390H7FX
00877466000383H6FX
00877466000376HCE101
00877466000369HCS3002-5
00877466000352HCS3021-5
00877466000345HCS3012-5
00877466000338HCS3011-5
00877466000321HCP01
00877466000307HC2T
00877466000277HCM101
00877466005777ADT1002-10
00877466005760ADT1001-10
00877466000239HVT101
00877466000222HVT100
00877466000123HT363
00877466000116HT360
00877466000062HT353
00877466000055HT353
00877466000048HT350
00877466006897HT353C
00877466005951HT354C
00877466005708HQE6AU
00877466005692HQE4AU
00877466005647AOS1005
00877466005630HQD12XL-M20
00877466005623HQD10XL-M16
00877466005616HQD9XL-M14
00877466005609HQD8XL-M12
00877466005593HQD7XL-M10
00877466005586HQD6XL-M9
00877466005579HQD5XL-M8
00877466005562HQD4XL-M7
00877466005555HQD4XL-M6

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