FDA.reportPublic FDA data

Clear Image Singles Lite

Primary DI
30856724004593
Brand
Clear Image Singles Lite
Company
NEXT MEDICAL PRODUCTS, LLC
Model
06-100-030
Published
2023-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
30856724004593PrimaryGS10
10856724004117Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085672400459330856724004593
1085672400411710856724004117

GMDN Terms#

Term, Definition table
TermDefinition
Skin topical coupling gelA medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system,) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light, blood gas) that pass through the skin during an examination or treatment. Also known as contact gel, it is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
078566628
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30856724004364Clear Image Singles02-100-0302023-06-12
30856724004371Clear Image Singles Sterile04-048-3002023-06-12
30856724004418Clear Image Singles Sterile04-048D2023-06-12
30856724004425ClearWave1024122023-06-12
30856724004456LithoClear11-60122023-06-12
30856724004463LithoClear11-04242023-06-12
30856724004487NovaplusV02-8122023-06-12
30856724004494NovaplusV05-8122023-06-12
30856724004500NovaplusV02-400B-0302023-06-12
30856724004517NovaplusV06-400B-0302023-06-12
30856724004524NovaplusV02-400-0302023-06-12
30856724004531NovaplusV06-400-0302023-06-12
30856724004609chattanooga42482023-06-12
30856724004432Clear Image02-60122023-06-12
30856724004449Clear Image05-60122023-06-12
07350025911205Vitrolife142132020-10-05
10856724004179Clear Image02-1052016-10-24
10856724004186Clear Image05-1052016-10-24
30856724004012Clear Image02-9122016-10-24
30856724004029Clear Image02-4052016-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.IYO2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08800290031522HERA Z20e Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-01-20
08056304455826MyLabC25ESAOTE SPAIYO2025-12-10
08056304455833MyLabC30ESAOTE SPAIYO2025-12-10
08800290041705miniER7SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041934LA2-9SSAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041941CMV1-10SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042184PA1-5ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042542EV2-12SAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042603CV1-8ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290042665CA3-10ASAMSUNG MEDISON CO., LTD.IYO2025-12-05
08800290041699L3-22SAMSUNG MEDISON CO., LTD.IYO2025-10-13
08800290042122LA2-16SSAMSUNG MEDISON CO., LTD.IYO2025-10-13
08800290042788LA2-14ASAMSUNG MEDISON CO., LTD.IYO2025-10-13
08800290042849CA1-7SSAMSUNG MEDISON CO., LTD.IYO2025-10-13