FDA.reportPublic FDA data

NovaKit™ 2 Exam Pack

Primary DI
00850681007351
Brand
NovaKit™ 2 Exam Pack
Company
Novasignal Corp.
Model
25-00004
Catalog number
NSC-NVK
Published
2022-08-19
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
true

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213279000NovaGuide 2 Intelligent UltrasoundNovasignal Corporation2022-03-02IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850681007351PackageGS110In Commercial Distribution
00850681007283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850681007351008506810073518506810073510850681007351
00850681007283008506810072838506810072830850681007283

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive vascular ultrasound support kitA collection of non-sterile, non-powered, noninvasive devices intended to support a noninvasive vascular ultrasound system during location and assessment of vascular flow using ultrasound/Doppler/transit time technology. It consists of non-electronic supportive devices such as patient pads/positioners, transducer covers, and skin marking stickers. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078766464
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
true
Expiration date on label
true
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
00850681007399NovaGuide™ 2 Intelligent Ultrasound System05-00030NSC-NVGSYS22022-08-19
00850681007405NovaGuide™ 2 Traditional Ultrasound SystemNSC-TCDNG2NSC-TCDNG22022-08-19
00850681007443NovaGuide™ Intelligent Ultrasound System05-00019NA-RBTSYS12022-08-19
00850681007221Lucid Transcranial Doppler Ultrasound System (Lucid TCD)NA-LUCM1NA-LUCM12020-08-31
00850681007009Lucid Transcranial Doppler SystemM1NA – LUCM12017-05-10
008506810070162-MHz Transducer, Handheld40-00008NA – PRB12017-05-25
008506810070232-MHz Headset/Monitoring Transducer40-00009NA - PRB22017-05-25
00850681007030Temporal Monitoring Headset40-00010NA – MOUNT12017-05-25
00850681007047Remote Control Accessory10-00002NA-ACC22018-03-20
008506810071532Mhz Monitoring Transducer - 8 footNA-PRB3NA-PRB32018-10-17
00850681007160Temporal Monitoring HeadframeNA-MOUNT2NA-MOUNT22018-10-17
00850681007177Monitoring Headframe Foam Procedural SetNA-DSP3NA-DSP32018-10-17
00850681007283NovaKit™ 2 Exam Pack25-00004NSC-NVK2022-08-19
00850681007184NovaBot Automated HeadsetNA-RBT1NA-RBT12020-08-31
10850681007174Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-PackNA-DSP3PKNA-DSP3PK2020-06-05
00850681007115NeuralBot Procedural Set (Single Use)1.xNA-DSP22018-07-26
00850681007122NeuralBot1.xNA-RBT12018-07-09
00850681007191NovaKit Exam Pack (NovaKit)NA-DSP2NA-DSP22020-08-31
10850681007198NovaKit Exam Pack (NovaKit)NA-DSP2NA-DSP22020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYN2026-04-03
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYN2025-12-05
08800290042665CA3-10ASAMSUNG MEDISON CO., LTD.IYN2025-12-05
08800290041699L3-22SAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042122LA2-16SSAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042788LA2-14ASAMSUNG MEDISON CO., LTD.IYN2025-10-13
08800290042849CA1-7SSAMSUNG MEDISON CO., LTD.IYN2025-10-13
08056304455031MyLabOmega eXPESAOTE SPAIYN2023-12-14
08056304454676MyLabX9ESAOTE SPAIYN2023-06-13
08800013544001X-CUBE 50Alpinion Medical Systems Co., Ltd.IYN2022-11-01
08800013545008X-CUBE 60Alpinion Medical Systems Co., Ltd.IYN2022-11-01
08800013511171C1-6CAlpinion Medical Systems Co., Ltd.IYN2022-07-15
08800013511164C1-7GTAlpinion Medical Systems Co., Ltd.IYN2022-02-05
08800013542007X-CUBE i8Alpinion Medical Systems Co., Ltd.IYN2022-02-05
08800013543004X-CUBE i9Alpinion Medical Systems Co., Ltd.IYN2022-02-05
08800076600119SC1FCUIYN2021-11-01
08800076600133Sono ChampionFCUIYN2021-11-01
08800076600140Sono ChangerFCUIYN2021-11-01
08800076600157Sono dot AIFCUIYN2021-11-01
08800076600010eZono1000FCUIYN2021-10-29
08800076600027Sonovation1LFCUIYN2021-10-29
08800076600034SOFRA1LFCUIYN2021-10-29
08800076600041SonoInfra1LFCUIYN2021-10-29
08800076600058Dr.SAFEFCUIYN2021-10-29
08800076600065ACUFRIENDFCUIYN2021-10-29
08800076600072ACUGUIDEFCUIYN2021-10-29
08800076600089ACUWAYFCUIYN2021-10-29
08800076600096AcuViz PocketFCUIYN2021-10-29