FDA.reportPublic FDA data

AccuGel

Primary DI
00851491007364
Brand
AccuGel
Company
Lynn Medical Instrument Co.
Model
AG-08
Catalog number
AG-08
Device description
ACCUGEL ULTRASOUND GEL .025 LITER DISPENSER
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012522000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012522000WAVELENGTH MULTI-PURPOSE ULTRASOUND GELNational Therapy Products, Inc.2001-10-18ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851491007361PackageGS112In Commercial Distribution
20851491007368PackageGS148In Commercial Distribution
00851491007364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085149100736110851491007361
2085149100736820851491007368
00851491007364008514910073648514910073640851491007364

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1888-596-6633customerservice@lynnmed.com

Regulatory Flags#

DUNS number
058810771
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851491007333AccuGelAG-50CL-HVAG-50CL-HV2017-02-13
00851491007340AccuGelAG-50AG-502017-02-13
00851491007531AccuSensor915-100915-1002020-08-31
10851491007538AccuSensor915-100915-1002020-08-31
00851491007548AccuSensor910-100910-1002020-06-25
00851491007487Direct IV Solutions - IV Start Kit2533-20G2533-20G2020-04-23
00851491007500Direct IV Solutions - IV Start Kit2534-20G2534-20G2020-04-23
00851491007517Direct IV Solutions - IV Start Kit2533-22G2533-22G2020-04-23
00851491007524Direct IV Solutions - IV Start Kit2534-22G2534-22G2020-04-23
20851491007481Direct IV Solutions - IV Start Kit2533-20G2533-20G2020-04-23
10851491007507Direct IV Solutions - IV Start Kit2534-20G2534-20G2020-04-23
10851491007514Direct IV Solutions - IV Start Kit2533-22G2533-22G2020-04-23
10851491007521Direct IV Solutions - IV Start Kit2534-22G2534-22G2020-04-23
00851491007470Lynn Medical - Ambulatory Kit3111353111352018-10-24
00851491007425Lynn Medical - Ambulatory Kit3112103112102018-10-10
00851491007432Lynn Medical - Ambulatory Kit3112123112122018-10-10
00851491007449Lynn Medical - Ambulatory Kit3112113112112018-10-10
00851491007456Lynn Medical - Ambulatory Kit3112133112132018-10-10
00851491007463Lynn Medical - Ambulatory Kit3112143112142018-10-10
10851491007422Lynn Medical - Ambulatory Kit3112103112102018-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08800290027266PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027419LA2-9SDSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290028638CA2-8ADSAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029390EV2-10ASAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290029420CV1-8AESAMSUNG MEDISON CO., LTD.ITX2026-04-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.ITX2026-01-28
08800289975974R30 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289976025R20 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979224EA2-11ARnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800289979262CA1-7SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027297PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027334LA2-9SnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08800290027365CA3-10AnSAMSUNG MEDISON CO., LTD.ITX2026-01-20
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08800289979132cV4 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08800289981883cV5 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-09-03
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
08800289970351cV8 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2025-02-27