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
00851491007555AccuSensorST-50ST-502026-07-28
00851491007562AccuSensorST-50ST-502026-07-24
00851491007142Lynn Medical - Ambulatory Kit3111163111162018-10-08
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
00851491007012AccuSensor930-100930-1002016-12-09
00851491007029AccuSensor950-100950-1002016-12-09
00851491007036AccuSensor990-100990-1002016-12-09
00851491007043AccuSensor550-048550-0482016-12-09
00851491007128AccuSensor310-050TS310-050TS2016-12-09
00851491007135AccuSensorLM33-1-30LM33-1-302016-12-09
00851491007159AccuSensor630-005630-0052016-12-09
00851491007166AccuSensor630-030630-0302016-12-09
00851491007173AccuSensor690-005690-0052016-12-09
00851491007548AccuSensor910-100910-1002020-06-25
00851491007074AccuSensor510-005510-0052016-12-09
00851491007111AccuSensorST-50ST-502016-12-09
00851491007333AccuGelAG-50CL-HVAG-50CL-HV2017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
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