FDA.reportPublic FDA data

UST-990-5

Primary DI
04573596213643
Brand
UST-990-5
Company
FUJIFILM HEALTHCARE CORPORATION
Model
UST-990-5
Device description
Probe
Published
2021-07-17
Public version status
New
Distribution status
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
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562122955836PreviousGS10
04573596213643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562122955836045621229558364562122955836
04573596213643045735962136434573596213643

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
718262719
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573596204382FUJIFILMFCT iStream 2024-07-12
04573596212011L31KPL31KP2024-01-25
04573596212318S3ESCLSS3ESCLS2024-01-25
04573596212035L35L352024-01-22
04573596212455UST-2266-5UST-2266-52024-01-22
04573596214176CL4416R1CL4416R12024-01-22
04573596214336C421C4212024-01-22
04573596214503CC41R2CC41R22024-01-22
04573596214510C253AC253A2024-01-22
04573596214527ARIETTA x10ARIETTA x102024-01-22
04573596212691UST-5311-TIPUST-5311-TIP2022-09-09
04573596214381ARIETTA 650ARIETTA 6502022-02-07
04573596213247UST-9113P-3.5UST-9113P-3.52021-07-19
04573596210062ASU-1013ASU-10132021-07-18
04573596210079ASU-1014ASU-10142021-07-18
04573596210116BA-001BA-0012021-07-18
04573596210260MP-2448MP-24482021-07-17
04573596210345MP-2456MP-24562021-07-17
04573596210352MP-2458MP-24582021-07-17
04573596210376MP-2473MP-24732021-07-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
06974405095166CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM ADVANCED INSTRUMENTATIONS, INC.IYO2026-03-24
10841716103992ACIST HDi™ CartACIST MEDICAL SYSTEMS, INC.IYO2026-03-04
04987670102813DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-03-01
06975345060108Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.IYO2026-01-31
16978669290012Astrasono A5Pro Bladder ScannerAstrasono technology co.,ltd.IYO2026-01-15
20841436126346Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00198953042816LOGIQGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-12-05
00841517112141Sonosite MTFUJIFILM SONOSITE, INC.IYO2025-11-24
00841517112196Sonosite MTFUJIFILM SONOSITE, INC.IYO2025-11-24
16978669290005Astrasono A3Pro Bladder ScannerAstrasono technology co.,ltd.IYO2025-11-20
00198953001431Venue GoGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-11-17
00198953079256VscanGE Vingmed Ultrasound ASIYO2025-11-17
00845225012984Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationIYO2025-08-22
06971679948945Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co.,Ltd.IYO2025-08-05
00198953001073VenueGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-07-31
00198953001097Venue GoGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-07-31
06938396400484SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400965SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400972SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400989SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400996SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401016SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401023SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401030SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401047SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21