FDA.reportPublic FDA data

STERILE AQUASONIC

Primary DI
20855683006023
Brand
STERILE AQUASONIC
Company
PARKER LABORATORIES INC
Model
ULTRASOUND TRANSMISSION GEL
Catalog number
01-01-4
Device description
Sterile Aquasonic 100 Ultrasound Transmission gel, 20g packette
Published
2016-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
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
20855683006023PrimaryGS10
00855683006029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085568300602320855683006023
00855683006029008556830060298556830060290855683006029

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002449593
Device count
400
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855683006821Aquaflex04-152026-10-01
00855683006845Aquaflex04-402026-10-01
10855683006705Aquasonic Clear03-202026-09-24
00303410000012AquaflexULTRASOUND GEL PAD 04-92-8203112025-05-30
00303410000029AquaflexULTRASOUND GEL PAD 04-90-8203112024-08-28
00303410000036AquaflexULTRASOUND GEL PAD 04-95-8203112024-11-20
00855683006579Delphinus Sequr™ Breast Interface99-176-7809622023-01-24
10855683006576Delphinus Sequr™ Breast Interface99-176-7809622023-01-24
00855683006005STERILE AQUASONICULTRASOUND TRANSMISSION GEL01-012016-12-19
10303410000019AquaflexULTRASOUND GEL PAD 04-92-8203112025-05-30
10855683006965ULTRADRAPE 2Ultrasound Guided Peripheral Intravenous Barrier a34-102025-05-20
20855683006962ULTRADRAPE 2Ultrasound Guided Peripheral Intravenous Barrier a34-102025-05-20
10303410000033AquaflexULTRASOUND GEL PAD 04-95-8203112024-11-20
10303410000026AquaflexULTRASOUND GEL PAD 04-90-8203112024-08-28
10855683006866Eclipse Probe Cover38-01-12021-12-31
00855683006739Timm Medical57-05-1447382019-11-11
10855683006347ECLIPSEPROBE COVER-LATEX FREE38-012016-12-19
10855683006354ECLIPSEPROBE COVER-LATEX FREE38-032016-12-19
10855683006361AQUAGELLUBRICATING GEL57-052016-12-19
00855683006371AQUAGELLUBRICATING GEL57-202016-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770033463055FETOLYDIAGNOLYIYO2026-10-22
00198953083246VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGIYO2026-10-09
06948941160022Bladder ScannerMeda Co., LtdIYO2026-10-08
00855683006821AquaflexPARKER LABORATORIES INCIYO2026-10-01
00855683006845AquaflexPARKER LABORATORIES INCIYO2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.IYO2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.IYO2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationIYO2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.IYO2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SIYO2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SIYO2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCIYO2026-09-18
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.IYO2026-08-18
00841436125420Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126212Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126229Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126328Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126588Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436126595Tracking BracketCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-27
00841436125413Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2026-07-23
08809887550125EdgeFlow UH10SEdgeCare Inc.IYO2026-06-19