FDA.reportPublic FDA data

Aquasonic Clear

Primary DI
10855683006705
Brand
Aquasonic Clear
Company
PARKER LABORATORIES INC
Model
03-20
Device description
Aquasonic Clear 20g Pouch Ultrasound Transmission Gel
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MUIMedia, Coupling, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUIMedia, Coupling, UltrasoundRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20855683006702PackageGS14In Commercial Distribution
10855683006705PrimaryGS10
00855683006708Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085568300670220855683006702
1085568300670510855683006705
00855683006708008556830067088556830067080855683006708

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
002449593
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
20855683006023STERILE AQUASONICULTRASOUND TRANSMISSION GEL01-01-42016-12-19
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
10855683006545Ultradrape34-152023-09-18
10855683006910BrainScope99-1000-0042023-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344130252MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-04-09
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00197344130279MEDLINEMEDLINE INDUSTRIES, INC.MUI2026-01-23
10665973032631DukalDukal LLCMUI2026-01-12
10665973032648DukalDukal LLCMUI2026-01-12
10665973032655DukalDukal LLCMUI2026-01-12
10665973032662DukalDukal LLCMUI2026-01-12
20665973032638DukalDukal LLCMUI2026-01-12
20665973032645DukalDukal LLCMUI2026-01-12
30665973032659DukalDukal LLCMUI2026-01-12
30665973032666DukalDukal LLCMUI2026-01-12
10815112021402E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021419E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021426E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10815112021433E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021406E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021413E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021420E-Z-SCAN Low Viscosity UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
30815112021437E-Z-GEL UltraSound GelBracco Diagnostics Inc.MUI2025-05-16
10197106849064CARDINAL HEALTHCardinal Health 200, LLCMUI2025-01-09
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20888277629841MEDLINEMEDLINE INDUSTRIES, INC.MUI2025-01-09
00850030915207RichmarSouth Dakota Partners Inc.MUI2023-08-02
00848340014857Asonic GelADVANCE MEDICAL DESIGNS, INC.MUI2023-06-13
10848340014854Asonic GelADVANCE MEDICAL DESIGNS, INC.MUI2023-06-13
10080196306237MedlineMEDLINE INDUSTRIES, INC.MUI2023-01-04
40080196306238MedlineMEDLINE INDUSTRIES, INC.MUI2023-01-04
00810113688473ManaMed IncManamed, Inc.MUI2022-12-31
10193489025293MedlineMEDLINE INDUSTRIES, INC.MUI2022-12-02
30193489025297MedlineMEDLINE INDUSTRIES, INC.MUI2022-12-02